NC QUANTUM APEX?
Report
- Report Number
- 2124215-2025-57805
- Event Type
- Malfunction
- Date Received
- August 20, 2025
- Date of Event
- July 28, 2025
- Report Date
- February 25, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- UDI-DI
- 08714729783473
- PMA / PMN Number
- K121667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1 - INITIAL REPORTER CITY: (B)(6). G4 - PREMARKET: K160823.
(B)(6). G4 - PREMARKET: K160823. THE NC QUANTUM APEX MR 20MM X 2.75MM WAS RETURNED FOR ANALYSIS IN THREE SECTIONS. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT IDENTIFIED A BREAK AT 3CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. A SECOND BREAK WAS NOTED AT 93.5CM PROXIMAL TO THE GUIDEWIRE EXCHANGE PORT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES. MICROSCOPIC INSPECTION REVEALED NO ISSUES WITH THE BALLOON MATERIAL OR TIP. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE.
E1 - INITIAL REPORTER CITY: (B)(6). G4 - PREMARKET: K160823. THE NC QUANTUM APEX MR 20MM X 2.75MM WAS RETURNED FOR ANALYSIS IN THREE SECTIONS. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT IDENTIFIED A BREAK AT 3CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. A SECOND BREAK WAS NOTED AT 93.5CM PROXIMAL TO THE GUIDEWIRE EXCHANGE PORT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES. MICROSCOPIC INSPECTION REVEALED NO ISSUES WITH THE BALLOON MATERIAL OR TIP. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE.
A2 AGE AT TIME OF EVENT, A2 UNIT OF MEASURE - AGE, A3A SEX, A3B GENDER: CORRECTED E1 - INITIAL REPORTER CITY: (B)(6). G4 - PREMARKET: K160823 THE NC QUANTUM APEX MR 20MM X 2.75MM WAS RETURNED FOR ANALYSIS IN THREE SECTIONS. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT IDENTIFIED A BREAK AT 3CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. A SECOND BREAK WAS NOTED AT 93.5CM PROXIMAL TO THE GUIDEWIRE EXCHANGE PORT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES. MICROSCOPIC INSPECTION REVEALED NO ISSUES WITH THE BALLOON MATERIAL OR TIP. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE.
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. DURING PREPARATION OF THE 20MM X 2.75MM NC QUANTUM APEX? BALLOON CATHETER, NO RESISTANCE WAS ENCOUNTERED WHILE REMOVING THE BALLOON PROTECTOR/MANDREL BUT AFTERWARD, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. DURING PREPARATION OF THE 20MM X 2.75MM NC QUANTUM APEX? BALLOON CATHETER, NO RESISTANCE WAS ENCOUNTERED WHILE REMOVING THE BALLOON PROTECTOR/MANDREL BUT AFTERWARD, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. DURING PREPARATION OF THE 20MM X 2.75MM NC QUANTUM APEX? BALLOON CATHETER, NO RESISTANCE WAS ENCOUNTERED WHILE REMOVING THE BALLOON PROTECTOR/MANDREL BUT AFTERWARD, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. DURING PREPARATION OF THE 20MM X 2.75MM NC QUANTUM APEX? BALLOON CATHETER, NO RESISTANCE WAS ENCOUNTERED WHILE REMOVING THE BALLOON PROTECTOR/MANDREL BUT AFTERWARD, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1295828 | NC QUANTUM APEX? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC CORPORATION | H7493912420270 | 0032847148 | 08714729783473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |