FDA Adverse Event
Malfunction
Summary report: N
HEARTSTRING II PROXIMAL SEAL SYSTEM
MDR report key: 1133743
·
Received August 20, 2008
Report
- Report Number
- 2953148-2008-00739
- Event Type
- Malfunction
- Date Received
- August 20, 2008
- Date of Event
- August 8, 2008
- Report Date
- August 13, 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
- HK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. A LOT HISTORY RECORD 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 A CORONARY ARTERY BYPASS GRAFT SURGERY, ONE HEARTSTRING SEAL'S TENSION SPRING TETHERS SEPARATED FROM THE SEAL DURING INSERTION INTO THE AORTA. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTRING II PROXIMAL SEAL SYSTEM | DXC | GUIDANT CARDIAC SURGERY | HS-1045 | 7121072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |