FDA Adverse Event
Malfunction
Summary report: N
NC QUANTUM APEX?
MDR report key: 21798534
·
Received April 8, 2025
Report
- Report Number
- 2124215-2025-21587
- Event Type
- Malfunction
- Date Received
- April 8, 2025
- Date of Event
- March 11, 2025
- Report Date
- April 8, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- PMA / PMN Number
- K121667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
E1 INITIAL REPORTER ADDRESS: (B)(6). G4 PREMARKET / 510(K) #: K160823. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
Description of Event or Problem · 0
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ANGINA AND UNDERGONE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. A 15MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS USED BUT THE BALLOON BLASTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 585258 | NC QUANTUM APEX? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC CORPORATION | H7493912415250 | 0033202167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |