FDA Adverse Event
Malfunction
Summary report: N
POWERFLEX P3 4MM X 4CM, 135CM
MDR report key: 795711
·
Received December 9, 2004
Report
- Report Number
- 9610978-2004-01166
- Event Type
- Malfunction
- Date Received
- December 9, 2004
- Date of Event
- November 24, 2004
- Report Date
- December 9, 2004
- Manufacturer
- CORDIS EUROPA, N.V.
- Product Code
- LIT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
BALLOON RUPTURE LEAKAGE. THE REPORT FROM THE AFFILIATE INDICATED THAT A PATIENT WAS UNDERGOING BALLOON DILATATION TO A HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT FEMORAL ARTERY WITH 90% STENOSIS. THE BALLOON WAS PREPPED OUTSIDE THE PATIENT'S BODY. THE VESSEL WAS ACCESSED CONTRALATERALLY. THE 4MMX4CM POWERFLEX BALLOON WAS INTRODUCED AND INFLATED ONCE BELOW NOMINAL PRESSURE, WHEN IT RUPTURED. CONTRAST MEDIUM WAS NOTED TO BE LEAKING OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SYNERGY 4MMX4CM BSJ. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERFLEX P3 4MM X 4CM, 135CM | PTA CATHETERS | LIT | CORDIS EUROPA, N.V. | NA | R0104031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | AMPLAZ GUIDEWIRE| ATM25 SUMITOMO BAKELITE INFLATOR, |