NC QUANTUM APEX?
Report
- Report Number
- 2124215-2026-06567
- Event Type
- Malfunction
- Date Received
- February 5, 2026
- Date of Event
- January 7, 2026
- Report Date
- April 29, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- UDI-DI
- 08714729783473
- PMA / PMN Number
- K121667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
G4: PREMARKET 501(K): K160823. DEVICE EVALUATION BY MFR: THE RETURNED PRODUCT CONSISTED OF THE NC QUANTUM APEX. A VISUAL INSPECTION SHOWED A BREAK IN THE SHAFT POLYMER EXTRUSION 2MM DISTAL TO THE PROT EXCHANGE. THE DISTAL SECTION INCLUDING THE BALLOON WAS NOT RETURNED. THE EXPOSED CORE WIRE IN THE DISTAL SECTION WAS ALSO BENT. BASED ON THE AVAILABLE INFORMATION IT IS LIKELY THAT THIS REPORTED DAMAGE OCCURRED DUE TO PRODUCT HANDLING AND UNINTENTIONALLY EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM WHILE UNPACKING AND PREPARING FOR THE PROCEDURE. THIS INVESTIGATION IS ASSIGNED A MOST PROBABLE INVESTIGATION CONCLUSION CODE OF UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.
G4: PREMARKET 501(K): K160823.
A CORRECTION REPORT IS BEING SUBMITTED TO CAPTURE FURTHER INVESTIGATION INFORMATION. G4: PREMARKET 501(K): K160823. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE EVENT. DEVICE TECHNICAL ANALYSIS: A VISUAL INSPECTION OF THE DEVICE REVEALED A BREAK IN THE SHAFT 2MM DISTAL TO THE PORT EXCHANGE. THE DISTAL SECTION INCLUDING THE BALLOON WERE NOT RETURNED. THE EXPOSED CORE WIRE IN THE DISTAL SECTION WAS BENT. LABELING REVIEW: BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS. RISK REVIEW: A RISK REVIEW WAS PERFORMED, AND IT CONFIRMED THAT THE EVENT WAS DEFINED IN THE RISK DOCUMENTATION AND IS RECORDED ACCORDINGLY IN THE PRODUCT RECORD REVIEW (PRR) TABLE. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON THE AVAILABLE INFORMATION IT IS LIKELY THAT THIS REPORTED DAMAGE OCCURRED DUE TO PRODUCT HANDLING AND UNINTENTIONALLY EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM WHILE UNPACKING AND PREPARING FOR THE PROCEDURE. THIS INVESTIGATION IS ASSIGNED A MOST PROBABLE INVESTIGATION CONCLUSION CODE OF UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.
IT WAS REPORTED THAT A DETACHMENT OCCURRED. AN NC QUANTUM APEX MR 2.75 X 20MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. WHEN REMOVING THE BALLOON FROM THE PROTECTOR, THE PHYSICIAN NOTED THAT THE BALLOON WAS CUT. THERE WERE NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT A DETACHMENT OCCURRED. AN NC QUANTUM APEX MR 2.75 X 20MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. WHEN REMOVING THE BALLOON FROM THE PROTECTOR, THE PHYSICIAN NOTED THAT THE BALLOON WAS CUT. THERE WERE NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT A DETACHMENT OCCURRED. AN NC QUANTUM APEX MR 2.75 X 20MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. WHEN REMOVING THE BALLOON FROM THE PROTECTOR, THE PHYSICIAN NOTED THAT THE BALLOON WAS CUT. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330558 | NC QUANTUM APEX? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC CORPORATION | H7493912420270 | 0036924732 | 08714729783473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |