FDA Adverse Event
Malfunction
Summary report: N
HEARTSTRING II PROXIMAL SEAL SYSTEM
MDR report key: 1181988
·
Received September 22, 2008
Report
- Report Number
- 2953148-2008-00793
- Event Type
- Malfunction
- Date Received
- September 22, 2008
- Date of Event
- August 26, 2008
- Report Date
- August 26, 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
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION RESULTS: THE VISUAL INSPECTION SHOWED THAT THE SEAL AND THE TENSION SPRING COMPONENTS WERE STILL LOADED INSIDE THE DEPLOYMENT TUBE. THE PLUNGER HAD BEEN DEPRESSED. 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 PROCEDURE, ONE HEARTSTRING SEAL DID NOT DEPLOY OUT OF THE DELIVERY TUBE INTO THE AORTA. A REPLACEMENT HEARTSTRING SEAL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTRING II PROXIMAL SEAL SYSTEM | DXC | GUIDANT CARDIAC SURGERY | HS-1045 | 8051971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |