FDA Adverse Event
Injury
Summary report: N
DELIVERY CATHETER SSPC2
MDR report key: 24877250
·
Received April 14, 2026
Report
- Report Number
- 2124215-2026-20169
- Event Type
- Injury
- Date Received
- April 14, 2026
- Date of Event
- March 17, 2026
- Report Date
- April 14, 2026
- Manufacturer
- CENTERPOINT SYSTEMS
- Product Code
- DQY
- UDI-DI
- 00810024671823
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS LEAD CATHETER HAD CAUSE LEAD DISLODGEMENT DURING RESULTING IN BENT HELIX. A NEW LEAD WAS PLACED AT NEW SITE WITHOUT COMPLICATIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 934539 | DELIVERY CATHETER SSPC2 | CATHETER, PERCUTANEOUS | DQY | CENTERPOINT SYSTEMS | 9182 | CL12868 | 00810024671823 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male | Hospitalization| R |