FDA Adverse Event
Injury
Summary report: N
IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
MDR report key: 5182844
·
Received October 28, 2015
Report
- Report Number
- 3004066202-2015-00464
- Event Type
- Injury
- Date Received
- October 28, 2015
- Date of Event
- August 3, 2015
- Report Date
- March 18, 2016
- Manufacturer
- INVATEC TECHNOLOGY CENTER GMBH
- Product Code
- ONU
- PMA / PMN Number
- P140010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION RECEIVED: CEC HAVE ADJUDICATED THAT THE CLAUDICATION OF THE RIGHT SFA WAS RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE OR DRUG.
Description of Event or Problem · 1
DURING INDEX PROCEDURE THE PHYSICIAN USED ONE IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE SFA OF THE RIGHT LEG (R1). APPROXIMATELY 1 YR AND 8 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED CLAUDICATION OF THE RIGHT SFA - 75% STENOSIS IN THE R1). THE INVESTIGATOR ASSESSED THAT THE EVENT IS POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE OR DRUG. THE PATIENT WAS TREATED WITH A NON MDT BALLOON. OUTCOME WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715450 | IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER | DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER | ONU | INVATEC TECHNOLOGY CENTER GMBH | 2E012808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00084 YR | Required Intervention |