FDA Adverse Event
Malfunction
Summary report: N
VIEWFLEX¿ XTRA ICE CATHETER
MDR report key: 12751088
·
Received November 4, 2021
Report
- Report Number
- 2030404-2021-00083
- Event Type
- Malfunction
- Date Received
- November 4, 2021
- Date of Event
- October 13, 2021
- Report Date
- December 1, 2021
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- OBJ
- PMA / PMN Number
- K133853
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: D9, G3, H2, H2. ONE VIEWFLEX XTRA ICE CATHETER WAS RECEIVED FOR EVALUATION. THE CATHETER TIP WAS NOTED TO BE BENT AND FRACTURED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.
Description of Event or Problem · 1
RELATED MANUFACTURING REF: 2030404-2021-00084. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER TIP WAS FRACTURED. THE CATHETER WAS EXCHANGED AND THE SAME ISSUE WAS NOTED. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1649408 | VIEWFLEX¿ XTRA ICE CATHETER | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | ST. JUDE MEDICAL, INC. | D087031 | 8080285 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | VIEWFLEX¿ XTRA ICE CATHETER| VIEWFLEX¿ XTRA ICE CATHETER |