FDA Adverse Event
Malfunction
Summary report: N
EMBOL-X SLIM ACCESS DEVICE/AORTIC CANNULA
MDR report key: 797176
·
Received December 7, 2004
Report
- Report Number
- 6000002-2004-00448
- Event Type
- Malfunction
- Date Received
- December 7, 2004
- Date of Event
- November 12, 2004
- Report Date
- November 12, 2004
- Manufacturer
- EDWARDS LIFESCIENCES RESEARCH MEDICAL
- Product Code
- DWF
- Removal / Correction Number
- 1713910-11/19/04-001R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION FOUND THAT THE J-CONNECTOR WAS DETACHED AT THE CANNULA BODY BOND. CORRECTIVE MEASURES ARE BEING ADDRESSED TO OPTIMIZE THE ADHESIVE BOND PROCESS OF THE EMBOL-X SLIM CANNULA. RESULTS: ADHESIVE BOND DETACHMENT.
Description of Event or Problem · 1
REPORTEDLY, THERE WAS BLOOD LEAKAGE AT THE JUNCTION WHERE THE J-TUBE CONNECTS TO THE CANNULA TUBE. THE CANNULA WAS USED THROUGHOUT THE CASE, WHICH LASTED APPROXIMATELY 1 HOUR. IT WAS REPORTED THAT THE LEAKAGE OCCURRED DURING THIS PERIOD OF TIME. THERE WERE NO PATIENT COMPLICATIONS OR INTERVENTION REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EMBOL-X SLIM ACCESS DEVICE/AORTIC CANNULA | AORTIC PERFUSION CANNULA | DWF | EDWARDS LIFESCIENCES RESEARCH MEDICAL | EX24D | 58174875 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |