FDA Adverse Event
Malfunction
Summary report: N
GUIDANT ACROBAT SUV STABILIZER
MDR report key: 1052734
·
Received May 23, 2008
Report
- Report Number
- 2953148-2008-00560
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- February 8, 2008
- Report Date
- April 5, 2008
- Manufacturer
- GUIDANT CARDIAC SURGERY
- Product Code
- MWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION RESULTS: FROM THE INVESTIGATION, THE PLUNGER HOUSING CAP (PLASTIC PIECE WITH GUIDANT LOGO) WAS SEPARATED FROM THE OM-9000 DEVICE AND NOT RETURNED. THE COMPLAINT WAS CONFIRMED FOR THE GUIDANT MOUNT PIECE SEPARATED FROM THE OM-9000S STABILIZER. A LHR REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE ATTRIBUTED TO THIS FAILURE MODE.
Description of Event or Problem · 1
THE HOSP REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS GRAFT SURGERY, THE PART OF THE MOUNT WHERE IT READS "GUIDANT" SEPARATED FROM ONE OM-9000S ACROBAT SUV VACUUM STABILIZER. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THE DETACHED PIECE WAS DISPOSED. THERE WERE NO PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDANT ACROBAT SUV STABILIZER | MWS | GUIDANT CARDIAC SURGERY | OM-9000S | 7092171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |