FDA Adverse Event
Malfunction
Summary report: N
N/A
MDR report key: 11738452
·
Received April 28, 2021
Report
- Report Number
- 3011610434-2021-00007
- Event Type
- Malfunction
- Date Received
- April 28, 2021
- Date of Event
- March 30, 2021
- Report Date
- April 28, 2021
- Manufacturer
- INNOVATIVE HEALTH, LLC.
- Product Code
- OWQ
- UDI-DI
- 10841898123252
- PMA / PMN Number
- K173262
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INNOVATIVE HEALTH, LLC BECAME AWARE OF AN INCIDENT WITH A VIEWFLEX XTRA ICE DEVICE ON (B)(6) 2021. IT WAS REPORTED THE CATHETER TIP HAD BECOME VERY BENT. UPON RECEIVING THE DEVICE FOR EVALUATION ON 08-APR-2021, IT WAS OBSERVED THE DISTAL TIP WAS PARTIALLY BROKEN. BASED ON THE REPORT RECEIVED, NO PATIENT INJURY WAS REPORTED, AND THE PROCEDURE CONTINUED WITH A DIFFERENT CATHETER.
Description of Event or Problem · 1
A VIEWFLEX XTRA ICE DIAGNOSTIC ULTRASOUND CATHETER MALFUNCTIONED AT THE TIP WHILE GOING THROUGH THE SHEATH. THE TIP BECAME VERY BENT. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 635212 | N/A | DIAGNOSTIC ULTRASOUND CATHETER | OWQ | INNOVATIVE HEALTH, LLC. | D087031 | 10841898123252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |