FDA Adverse Event
Injury
Summary report: N
EVERCROSS .035" OTW PTA DILATATION CATHETER
MDR report key: 3913678
·
Received July 3, 2014
Report
- Report Number
- 2183870-2014-00163
- Event Type
- Injury
- Date Received
- July 3, 2014
- Date of Event
- January 7, 2014
- Report Date
- June 4, 2014
- Manufacturer
- COVIDIEN
- Product Code
- LIT
- PMA / PMN Number
- K110319
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.
Additional Manufacturer Narrative · 1
THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN PLYMOUTH LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.
Description of Event or Problem · 1
THIS PROCEDURE WAS PART OF THE DURABILITY POST APPROVAL STUDY.ARTERIAL PERFORATION WAS OBSERVED AFTER AN ANGIOGRAPHIC CORE LAB TECHNICAL OBSERVATION. THIS WAS ADJUDICATED BY THE CLINICAL EVENT COMMITTEE AS RELATED TO THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391391 | EVERCROSS .035" OTW PTA DILATATION CATHETER | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | COVIDIEN | AB35W05150135 | 9840475 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |