FDA Adverse Event
Malfunction
Summary report: N
SUPERTORQUE 5F MARKER BAND FLUSH CATHETER
MDR report key: 3023706
·
Received March 27, 2013
Report
- Report Number
- 9616099-2013-00189
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- March 15, 2013
- Report Date
- March 19, 2013
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- DQO
- PMA / PMN Number
- K915836
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON REVIEW, THE MARKER BANDS DID NOT COME OFF THE DEVICE BUT MOVED FROM THE ORIGINAL POSITION, REMAINING ON THE DEVICE ITSELF. THEREFORE, THIS EVENT DOES NOT MEET THE CRITERIA OF A MALFUNCTION THAT REQUIRES REGULATORY REPORTING. AS SUCH, NO FURTHER REPORTS WILL BE FORTHCOMING REGARDING THIS EVENT.
Additional Manufacturer Narrative · 1
THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
Description of Event or Problem · 1
WHEN A 5F SUPERTORQUE PIGTAIL WAS REMOVED THE MARKERS HAD BEEN STRIPPED DOWN TO ONE SECTION OF THE CATHETER AFTER IT WAS USED TO SHOOT AN ANGIOGRAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125880 | SUPERTORQUE 5F MARKER BAND FLUSH CATHETER | DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) | DQO | CORDIS DE MEXICO | NA | 15608561 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |