FDA Adverse Event
Injury
Summary report: N
HEARTSTRING II PROXIMAL SEAL SYSTEM
MDR report key: 1102443
·
Received August 7, 2008
Report
- Report Number
- 2953148-2008-00709
- Event Type
- Injury
- Date Received
- August 7, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 31, 2008
- Manufacturer
- GUIDANT CARDIAC SURGERY
- Product Code
- DXC
- PMA / PMN Number
- K022880
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 WHILE UNPACKING, FOR A CORONARY ARTERY BYPASS GRAFT SURGERY, ONE HEARTSTRING SEAL CRACKED WAS FOUND CRACKED. THE SURGEON CONVERTED TO A SIDE CLAMP TO COMPLETE THE PROCEDURE. NO FURTHER PT COMPLICATIONS WERE REPORTED BY THE HOSPITAL AS A RESULT OF THE CLAMP CONVERSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTRING II PROXIMAL SEAL SYSTEM | DXC | GUIDANT CARDIAC SURGERY | HS-1045 | 8021871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |