FDA Adverse Event
Malfunction
Summary report: N
HEARTSTRING II PROXIMAL SEAL SYSTEM
MDR report key: 1102127
·
Received August 7, 2008
Report
- Report Number
- 2953148-2008-00712
- Event Type
- Malfunction
- Date Received
- August 7, 2008
- Date of Event
- June 16, 2008
- Report Date
- August 5, 2008
- Manufacturer
- GUIDANT CARDIAC SURGERY
- Product Code
- DXC
- PMA / PMN Number
- K022880
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. A LHR REVIEW WAS COMPLETED FOR THE PRODUCT, AND THERE WAS NO NONCONFORMANCE ASSOCIATED WITH THE LOT NUMBER.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS GRAFT SURGERY, ONE HEARTSTRING SEAL CRACKED DURING LOADING OF THE HEARTSTRING DEVICE. DURING THE SAME PROCEDURE, TWO HEARTSTRING SEALS DID NOT UNFOLD AFTER DEPLOYMENT INTO THE AORTA. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WERE NO PT CONSEQUENCES. THIS REPORT IS FOR THE SECOND SEAL THAT DID NOT UNFOLD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTRING II PROXIMAL SEAL SYSTEM | DXC | GUIDANT CARDIAC SURGERY | HS-1045 | 7120871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |