FDA Adverse Event
Injury
Summary report: N
PERQCATH 3 FR S/L W/GW I
MDR report key: 350666
·
Received September 7, 2001
Report
- Report Number
- 1720496-2001-00434
- Event Type
- Injury
- Date Received
- September 7, 2001
- Date of Event
- June 19, 2001
- Report Date
- August 8, 2001
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IMPLANTED IN 2001. ELEVEN DAYS LATER, WAS EXPLANTED BECAUSE PART OF THE CATHETER EMBOLIZED INTO THE PULMONARY ARTERY. CARDIOVASCULAR SURGEON RETRIEVED. NO FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40523 | PERQCATH 3 FR S/L W/GW I | LONG TERM INTRAVASCULAR CATHETER | DQO | BARD ACCESS SYSTEMS | 4133100 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |