FDA Adverse Event
Other
Summary report: N
POWERLINK SYSTEM
MDR report key: 725930
·
Received June 14, 2006
Report
- Report Number
- 2031527-2006-00017
- Event Type
- Other
- Date Received
- June 14, 2006
- Date of Event
- June 9, 2006
- Report Date
- June 14, 2006
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRELIMINARY EVALUATION CONFIRMS TIP SEPARATION CONSISTENT WITH PREVIOUSLY REPORTED FIELD ACTION, WITH MANUFACTURING PROCESS (172) AND OPERATIONAL CONTEXT (326) CONTRIBUTING TO THE EVENT. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED.
Description of Event or Problem · 1
A BIFURCATED DEVICE WAS SUCCESSFULLY DEPLOYED. IT WAS NOTED THAT THE PT HAD SMALL ILIAC ARTERIES. UPON RETRACTION OF THE DELIVERY CATHETER,THE TIP SEPARATED FROM THE FRONT SHEATH. THE PHYSICIAN REMOVED THE INTACT PORTION OF THE DELIVERY CATHETER, AND WAS ABLE TO RETRIEVE THE SEPARATED TIP VIA AN EXTENDED THE CUTDOWN WITH FORCEPS. PT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | INFRARENAL BIFURCATED DEVICE | MIH | ENDOLOGIX, INC. | 25-16-140BL | W05-1145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |