FDA Adverse Event
Malfunction
Summary report: N
ULTRASONIC IMAGING CATHETER - CORONARY
MDR report key: 3884654
·
Received June 19, 2014
Report
- Report Number
- 2134265-2014-03934
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Report Date
- June 3, 2014
- Manufacturer
- BOSTON SCIENTIFIC - FREMONT (SUD)
- Product Code
- DQO
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
Description of Event or Problem · 1
SAME CASE AS: 2134265-2014-03811 AND 2134265-2014-03933. IT WAS REPORTED THAT MOTOR DRIVE UNIT DOES NOT PULLBACK. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH A BSC CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT DURING PROCEDURE, MOTOR DRIVE UNIT DOES NOT PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361544 | ULTRASONIC IMAGING CATHETER - CORONARY | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | BOSTON SCIENTIFIC - FREMONT (SUD) | UNK97 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |