FDA Adverse Event
Malfunction
Summary report: N
NC QUANTUM APEX?
MDR report key: 3582124
·
Received January 17, 2014
Report
- Report Number
- 2134265-2014-00084
- Event Type
- Malfunction
- Date Received
- January 17, 2014
- Date of Event
- January 5, 2014
- Report Date
- January 6, 2014
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- LOX
- PMA / PMN Number
- K121667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 15MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE LESION FOR POST DILATION. THE BALLOON WAS INFLATED HOWEVER IT RUPTURED UNDER NOMINAL PRESSURE ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43995 | NC QUANTUM APEX? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC - MAPLE GROVE | H7493912415220 | 16173896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |