DELIVERY CATHETER SSPC3
Report
- Report Number
- 2124215-2026-09740
- Event Type
- Malfunction
- Date Received
- February 22, 2026
- Date of Event
- January 30, 2026
- Report Date
- March 31, 2026
- Manufacturer
- CENTERPOINT SYSTEMS
- Product Code
- DQY
- UDI-DI
- 00810024671830
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE LEAD CATHETER WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE LEAD CATHETER WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM.
IT WAS REPORTED THAT THIS ACCESSORY GUIDING CATHETER EXHIBITED A CURVE FORMATION FAILURE WHICH MIGHT BE DUE TO HEAT RELATED ANOMALY OR REPEATED REPOSITIONING WHICH THE LEAD COULD NO LONGER BE DIRECTED TANGENT TOWARD THE SEPTUM AND APPEARED UNABLE TO REACH THE SITE WHERE PLACEMENT WAS INITIALLY ATTEMPTED. THIS ACCESSORY WAS OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS ACCESSORY GUIDING CATHETER EXHIBITED A CURVE FORMATION FAILURE WHICH MIGHT BE DUE TO HEAT RELATED ANOMALY OR REPEATED REPOSITIONING WHICH THE LEAD COULD NO LONGER BE DIRECTED TANGENT TOWARD THE SEPTUM AND APPEARED UNABLE TO REACH THE SITE WHERE PLACEMENT WAS INITIALLY ATTEMPTED. THIS ACCESSORY WAS OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45991 | DELIVERY CATHETER SSPC3 | LEAD CATHETER ACCESSORY | DQY | CENTERPOINT SYSTEMS | 9183 | CL13184 | 00810024671830 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |