FDA Adverse Event
Injury
Summary report: N
BALLOON
MDR report key: 3053293
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-04893
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 20, 2013
- Report Date
- March 20, 2013
- Manufacturer
- EXTERNAL MANUFACTURER
- Product Code
- DYB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, NO RETURN OF PRODUCT IS INTENDED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT UPGRADE PROCEDURE,THIS BALLOON CATHETER WAS USED TO CREATE THE ROAD MAP. VISUAL OBSERVATION REVEALED CONTRAST LEAKING OUTSIDE THE CORONARY SINUS. IT WAS SUSPECTED A PERFORATION HAD OCCURRED. A NON-BOSTON SCIENTIFIC LEFT VENTRICULAR LEAD WAS SUCCESSFULLY IMPLANTED IN A LATERAL VEIN AND NO FURTHER INTERVENTION WAS REQUIRED. ALL MEASUREMENTS WERE ACCEPTABLE. NO ADVERSE PATIENT EFFECTS WERE EXPERIENCED AS A RESULT OF THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157009 | BALLOON | CATHETER | DYB | EXTERNAL MANUFACTURER | 6714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |