FDA Adverse Event
Malfunction
Summary report: N
ANGIOGUARD RX
MDR report key: 1190598
·
Received October 6, 2008
Report
- Report Number
- 1016427-2008-00254
- Event Type
- Malfunction
- Date Received
- October 6, 2008
- Date of Event
- September 22, 2008
- Report Date
- September 22, 2008
- Manufacturer
- CORDIS CORPORATION
- Product Code
- NTE
- PMA / PMN Number
- K062531
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
PER SALES REP, UPON RETRIEVAL OF THE ANGIOGUARD THE MEMBRANE WAS CAUGHT ON THE TIP OF THE STENT AND THE MEMBRANE TORE. PLEASE NOTE THAT MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGIOGUARD RX | EMBOLIC PROTECTION DEVICE (NTE) | NTE | CORDIS CORPORATION | NA | 70707510 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |