NC QUANTUM APEX?
Report
- Report Number
- 2124215-2025-47193
- Event Type
- Malfunction
- Date Received
- July 15, 2025
- Date of Event
- February 17, 2025
- Report Date
- July 15, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- UDI-DI
- 08714729783367
- PMA / PMN Number
- K121667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4: PREMARKET / 510(K): K160823. DEVICE EVALUATED BY MFR.: THE NC QUANTUM APEX MR 15 MM X 2.75 MM WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE. VISUAL AND TACTILE EXAMINATION IDENTIFIED MULTIPLE HYPOTUBE KINKS. A BREAK WAS IDENTIFIED IN THE INNER LUMEN UNDER THE BALLOON SECTION NEAR THE DISTAL TIP. THE BROKEN DISTAL SECTION DID NOT RETURN. A TEAR WAS IDENTIFIED IN THE BALLOON MATERIAL AND THE TORN DISTAL SECTION DID NOT RETURN. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL NOTED A CIRCUMFERENTIAL BALLOON TEAR 22.7CM FROM THE PORT EXCHANGE AND THE DISTAL SECTION WAS NOT RETURNED. THE DISTAL SECTION OF THE DEVICE DID NOT RETURN.
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30JUN2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED SEGMENT OF A CHRONIC TOTALLY OCCLUDED ARTERY. A 15 MM X 2.75 MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN CIRCUMFERENTIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128350 | NC QUANTUM APEX? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC CORPORATION | H7493912415270 | 0033639484 | 08714729783367 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |