FDA Adverse Event
Summary report: N
ABBOTT PERCLOSE PROGLIDE 6FR
MDR report key: 12878153
·
Received November 24, 2021
Report
- Report Number
- MW5105591
- Date Received
- November 24, 2021
- Report Date
- November 22, 2021
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- MGB
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ABBOTT PERCLOSE PROGLIDE 6 FR, LOT #: 1053041, PART #: 1267303 - 2 EVENTS ON SAME PATIENT. IN PATIENT'S LEFT FEMORAL ARTERY, WHEN DEPLOYING THE DEVICE IT "GOT STUCK". IN AN ATTEMPT TO REMOVE IT, THE DEVICE BROKE IN THE VESSEL. A CUTDOWN HAD TO BE PERFORMED ON THE PATIENT'S VESSEL TO RETRIEVE THE BROKEN PIECE AND REPAIR THE VESSEL. ON PATIENT'S RIGHT FEMORAL ARTERY, DECREASED BLOOD FLOW TO PATIENT'S FOOT NOTED AFTER DEPLOYMENT OF THE DEVICE ("RIGHT ILIAC DISSECTION OR ALSO PERCLOSE INJURY") NECESSITATING SURGICAL REPAIR. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1770065 | ABBOTT PERCLOSE PROGLIDE 6FR | DEVICE, HEMOSTASIS, VASCULAR | MGB | ABBOTT VASCULAR | 1267303 | 1053041 | |
| 1770066 | ABBOTT PERCLOSE PROGLIDE 6FR | DEVICE, HEMOSTASIS, VASCULAR | MGB | ABBOTT VASCULAR | 1267303 | 1053041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |