FDA Adverse Event
Malfunction
Summary report: N
HEARTSTRING II PROXIMAL SEAL SYSTEM
MDR report key: 1203208
·
Received October 17, 2008
Report
- Report Number
- 2953148-2008-00858
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Report Date
- September 23, 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
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION DETAILS: VISUAL INSPECTION SHOWS THAT THE SEAL WAS OUTSIDE OF DEPLOYMENT TUBE AND CRACKED. THE TENSION SPRING COMPONENTS WERE STILL LOADED INSIDE THE DEPLOYMENT TUBE. THE REPORTED COMPLAINT IS CONFIRMED FOR SEAL WOULD NOT DEPLOY. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT, 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 | 8051371 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |