FDA Adverse Event
Malfunction
Summary report: N
QUANTUM¿ MAVERICK¿
MDR report key: 2628333
·
Received June 26, 2012
Report
- Report Number
- 2134265-2012-03657
- Event Type
- Malfunction
- Date Received
- June 26, 2012
- Date of Event
- May 30, 2012
- Report Date
- May 30, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- LOX
- PMA / PMN Number
- P860019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE LESION WAS CALCIFIED. NO OTHER LESION DETAILS ARE AVAILABLE. ON THE FIRST INFLATION THE QUANTUM MAV MON 8MM X 4.0MM BALLOON RUPTURED AT TWELEVE ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THAT PATIENT'S STATUS IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUANTUM¿ MAVERICK¿ | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC - MAPLE GROVE | H7493808008400 | 12665650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |