FDA Adverse Event
Malfunction
Summary report: N
HEARTSTRING PROXIMAL SEAL, 4.5 MM
MDR report key: 2093916
·
Received April 19, 2011
Report
- Report Number
- 2242352-2011-00294
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 22, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC.
- Product Code
- DXC
- PMA / PMN Number
- K022880
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: THE PRODUCT WILL NOT BE RETURNED TO MAQUET FOR INVESTIGATION. THEREFORE, A DEVICE EVAL COULD NOT BE PERFORMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING II SEAL CRACKED DURING USE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTRING PROXIMAL SEAL, 4.5 MM | PROXIMAL SEAL | DXC | MAQUET CARDIOVASCULAR, LLC. | HS-1045 | 25012543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |