FDA Adverse Event
Malfunction
Summary report: N
GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL
MDR report key: 1030932
·
Received April 17, 2008
Report
- Report Number
- 2953148-2008-00394
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 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
- AZ, 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 WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION COMPLETED.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS GRAFT SURGERY, ONE HEARTSTRING SEAL FAILED TO DEPLOY OUT OF THE DELIVERY TUBE INTO THE AORTA. THE SURGEON USED A REPLACEMENT HEARTSTRING SEAL TO COMPLETE THE PROCEDURE. NO PT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL | DXC | GUIDANT CARDIAC SURGERY | HS-1045 | 8022071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |