PROGLIDE Adverse Event — Injury (MDR 2024168-2020-03980)
PROGLIDE Adverse Event — Injury (MDR 2024168-2020-03980) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROGLIDE; Generic name: SUTURE MEDIATED CLOSURE; Manufacturer: ABBOTT VASCULAR.
| Device | PROGLIDE |
|---|---|
| Generic name | SUTURE MEDIATED CLOSURE |
| Manufacturer | ABBOTT VASCULAR |
| Report number | 2024168-2020-03980 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IT SHOULD BE NOTED THAT THE PROGLIDE INSTRUCTIONS FOR USE STATES: REMOVE THE GUIDE WIRE BEFORE THE EXIT PORT CROSSES THE SKIN LINE. THE REPORTED EVENT APPEARS TO BE RELATED TO DEPLOYMENT OF THE SUTURE WITH GUIDE WIRE STILL IN PLA |
| Source | openFDA MAUDE (device adverse events) |
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