FDA Adverse Event
Malfunction
Summary report: N
PTA AMIIA, 5.0 X 40MM, 142CM
MDR report key: 902515
·
Received October 22, 2004
Report
- Report Number
- 9610978-2004-01085
- Event Type
- Malfunction
- Date Received
- October 22, 2004
- Date of Event
- October 4, 2004
- Report Date
- October 22, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORT WE RECEIVED INDICATED THAT THERE WAS BALLOON/ LEAKAGE/ RUPTURE. THIS PRODUCT (423-5040W) WAS USED FOR POST-DILATION. THE BALLOON WAS RUPTURED AT NBP AT SECOND INFLATION (PRESSURE, TIME UNKNOWN). STENT: EASY WALL (BSJ/SIZE UNKNOWN). GW: GRANDSLAM (BRAND UNKNOWN). THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING VALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS DEVICE (4235040W/LOT R0104584) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT 4225040X).
Description of Event or Problem · 1
BALLOON/ LEAKAGE AND RUPTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PTA AMIIA, 5.0 X 40MM, 142CM | PTA CATHETERS | LIT | CORDIS EUROPA, N.V. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |