FDA Adverse Event
Malfunction
Summary report: N
HEARTSTRING III PROXIMAL SEAL SYSTEM
MDR report key: 1213121
·
Received October 23, 2008
Report
- Report Number
- 2953148-2008-00867
- Event Type
- Malfunction
- Date Received
- October 23, 2008
- Date of Event
- September 12, 2008
- Report Date
- October 3, 2008
- Manufacturer
- GUIDANT CARDIAC SURGERY
- Product Code
- DXC
- PMA / PMN Number
- K080169
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE TO PURSUE THE DEVICE BEING RETURNED TO CARDIAC SURGERY FOR INVESTIGATION WITH THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION COMPLETED.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, ONE HEARTSTRING SEAL DID NOT DEPLOY OUT OF THE DELIVERY TUBE INTO THE AORTA. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WERE NO PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTRING III PROXIMAL SEAL SYSTEM | DXC | GUIDANT CARDIAC SURGERY | HS-3045 | 8082071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |