STRMR,XDISSUP SPT,J,195-014
Report
- Report Number
- 3006010712-2023-00059
- Event Type
- Malfunction
- Date Received
- January 2, 2024
- Date of Event
- December 12, 2023
- Report Date
- February 7, 2024
- Manufacturer
- LAKE REGION MEDICAL
- Product Code
- DQX
- PMA / PMN Number
- K083094
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 501
Narratives
COMPLAINT INVESTIGATION REPORT IS ATTACHED TO THIS REPORT.
COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.
DURING A CRT-D PROCEDURE, SENTUS PROMRI OTW QP L-85/49 WAS PLACED IN THE LV. WHEN PHYSICIAN TRIED TO REMOVE THE STREAMER GUIDE WIRE (IN ORDER TO INTRODUCE THE STYLET TO PROCEED WITH THE SELECTRA PEEL AWAY), THE GUIDE WIRE STUCK IN THE PROXIMAL AREA OF THE LEAD, ALMOST REACHING THE CONNECTOR PIN. WHEN PHYSICIAN TRIED TO PULL OUT THE STREAMER, IT BROKE IN TWO PIECES, REMAINING THE TIP OF THE WIRE INSIDE THE LEAD LUMEN. HE WAS FORCED TO REMOVE THAT LEAD FROM THE BODY AND IMPLANT A NEW ONE AGAIN.
DURING A CRT-D PROCEDURE, SENTUS PROMRI OTW QP L-85/49 WAS PLACED IN THE LV. WHEN PHYSICIAN TRIED TO REMOVE THE STREAMER GUIDE WIRE (IN ORDER TO INTRODUCE THE STYLET TO PROCEED WITH THE SELECTRA PEEL AWAY), THE GUIDE WIRE STUCK IN THE PROXIMAL AREA OF THE LEAD, ALMOST REACHING THE CONNECTOR PIN. WHEN PHYSICIAN TRIED TO PULL OUT THE STREAMER, IT BROKE IN TWO PIECES, REMAINING THE TIP OF THE WIRE INSIDE THE LEAD LUMEN. HE WAS FORCED TO REMOVE THAT LEAD FROM THE BODY AND IMPLANT A NEW ONE AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1204135 | STRMR,XDISSUP SPT,J,195-014 | STRMR,XDISSUP SPT,J,195-014 | DQX | LAKE REGION MEDICAL | 363727 | 8639927 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |