FDA Adverse Event
Injury
Summary report: N
ANGIOGUARD RX ECGW 6MM X 180CM - EXTRA SUPPORT
MDR report key: 1062916
·
Received June 19, 2008
Report
- Report Number
- 1016427-2008-00176
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- May 25, 2008
- Report Date
- May 25, 2008
- Manufacturer
- CORDIS CORPORATION
- Product Code
- NTE
- PMA / PMN Number
- K062531
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
Description of Event or Problem · 1
THE PT WAS A MALE. THE LESION WAS LOCALIZED JUST OVER THE BULB. IT WAS A 70% CALCIFIED LESION. DURING THE PROCEDURE, ONE OF THE MARKER BANDS OF THE ANGIOGUARD EMBOLIC PROTECTION DEVICE DISLODGED IN THE PT. THE MARKER BAND CAUSED A TRANSITORY OCCLUSION OF ONE SMALL CEREBRAL VESSEL. THE PT HAD TRANSITORY PARALYSIS IN THE RIGHT HAND FOR 40 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGIOGUARD RX ECGW 6MM X 180CM - EXTRA SUPPORT | EMBOLIC PROTECTION DEVICE (NTE) | NTE | CORDIS CORPORATION | NA | 70807510 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Life Threatening |