FDA Adverse Event
Malfunction
Summary report: N
POWERFLEX P3 6MM X 4CM, 40CM
MDR report key: 5113866
·
Received November 24, 2004
Report
- Report Number
- 1016427-2004-00011
- Event Type
- Malfunction
- Date Received
- November 24, 2004
- Date of Event
- November 1, 2004
- Report Date
- November 24, 2004
- Manufacturer
- CORDIS EUROPA, N.V.
- Product Code
- LIT
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS REPORTED BY OUR AFFILIATE, DURING A SHUNT PTA, THE BALLOON RUPTURED AT 10 ATM ON THE SECOND DILATION. THE VESSEL WAS CALCIFIED. THE PROCEDURE WAS COMPLETED WITH SYNERGY (BSJ/SIZE UNKNOWN). THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, THE PRODUCT HAS NOT BEEN RETURNED AS OF THIS DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
Description of Event or Problem · 1
BALLOON RUPTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERFLEX P3 6MM X 4CM, 40CM | PTA CATHETERS | LIT | CORDIS EUROPA, N.V. | NA | R0404457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |