FDA Adverse Event
Malfunction
Summary report: N
GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL
MDR report key: 1001729
·
Received February 19, 2008
Report
- Report Number
- 2953148-2008-00170
- Event Type
- Malfunction
- Date Received
- February 19, 2008
- Date of Event
- January 30, 2008
- Report Date
- January 30, 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
- TN, 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 HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THREE HEARTSTRING SEALS DID NOT DEPLOY OUT OF THE DELIVERY TUBE INTO THE AORTA AND ONE HEARTSTRING SEAL BEGAN TO UNRAVEL WHILE LOADING THE SEAL INTO THE DELIVERY TUBE. A REPLACEMENT HEARTSTRING SEAL WAS USED TO COMPLETE THE PROCEDURE. NO PT COMPLICATIONS WERE REPORTED BY THE HOSP. THIS REPORT IS FOR THE THIRD SEAL.
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 | 8011271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |