PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM Adverse Event — Injury (MDR 2024168-2020-03968)
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM Adverse Event — Injury (MDR 2024168-2020-03968) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM; Generic name: SUTURE MEDIATED CLOSURE; Manufacturer: ABBOTT VASCUL
| Device | PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM |
|---|---|
| Generic name | SUTURE MEDIATED CLOSURE |
| Manufacturer | ABBOTT VASCULAR |
| Report number | 2024168-2020-03968 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE INFORMATION REVIEWED, THE REPORTED DIFFICULTY AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE |
| Source | openFDA MAUDE (device adverse events) |
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