SKATER INTRODUCER SYSTEM Adverse Event — Malfunction (MDR 1625425-2020-00302)
SKATER INTRODUCER SYSTEM Adverse Event — Malfunction (MDR 1625425-2020-00302) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SKATER INTRODUCER SYSTEM; Manufacturer: ARGON MEDICAL DEVICES; Report number: 1625425-2020-00302.
| Device | SKATER INTRODUCER SYSTEM |
|---|---|
| Manufacturer | ARGON MEDICAL DEVICES |
| Report number | 1625425-2020-00302 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | DISTRIBUTOR |
| Narrative | CAPA (B)(4) HAS BEEN INITIATED TO ADDRESS THE GUIDEWIRE DETACHMENT ISSUE. THE CAPA WILL DOCUMENT THE ROOT CAUSES IDENTIFIED AND THE CORRECTIVE ACTIONS TAKEN TO ADDRESS THE ISSUE. FIELD ACTION IS REQUIRED, PRODUCT WILL BE RECALLED. |
| Source | openFDA MAUDE (device adverse events) |
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