FDA Adverse Event
Malfunction
Summary report: N
OPN NC 4.5 X 15 PTCA DILATATION CATHETER
MDR report key: 24986694
·
Received April 24, 2026
Report
- Report Number
- 3013634084-2026-00001
- Event Type
- Malfunction
- Date Received
- April 24, 2026
- Date of Event
- March 27, 2026
- Report Date
- April 20, 2026
- Manufacturer
- SIS MEDICAL AG
- Product Code
- LOX
- UDI-DI
- 07640142572893
- PMA / PMN Number
- K212393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
A REVIEW OF THE DHR HAS BEEN PERFORMED AND THE LOT IS WITHIN SPECIFICATIONS. THE COMPLAINT DEVICE HAS BEEN RETURNED FOR INVESTIGATION, AND THE EVALUATION PROCESS HAS BEEN INITIATED. A SUPPLEMENTARY REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 0
A HOSPITAL INFORMED SIS MEDICAL THAT AN ISSUE HAS BEEN ENCOUNTERED WITH AN OPN NC 4.5X15 MM LOT 212869. A SUBSEQUENT MATERIOVIGILANCE REPORT SUBMITTED BY THE HOSPITAL TO SIS MEDICAL INDICATED THAT THE SHAFT OF THE BALLOON BROKE, AND THAT THERE WERE NO SERIOUS CONSEQUENCES FOR THE PATIENT. ADDITIONAL DETAIL HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 427393 | OPN NC 4.5 X 15 PTCA DILATATION CATHETER | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS (PTCA CATHETER) | LOX | SIS MEDICAL AG | OPN NC | 212869 | 07640142572893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |