N
Patient 1
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.
MAUDE MDR 4730748
- MDR report key
- 4730748
- Report number
- 1820334-2015-00215
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-03-26
- Date received
- 2015-04-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LARRY POOL,MANAGER
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | INDY OTW VASCULAR RETRIEVER | GAE SNARE, SURGICAL | COOK, INC. | GAE | NA | INDY-8.0-35-100-40 | 5667083 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-04-22 | 0 | 1. R |
Event Narratives#
D
Patient 1
AN EVAR WITH A ILIAC BRANCH DEVICE IMPLANTATION WAS BEING PERFORMED ON A (B)(6) MALE PATIENT. THE DOCTOR CAUGHT THE WIRE IN THE SNARE AND PULLED WITH SOME FORCE. THE INDY SNARE SNAPPED AND WAS LEFT FLOATING WITHIN THE AORTA. A CLOVER SNARE WAS THEN USED TO RETRIEVE THE PART OF THE INDY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
N
Patient 1
THE COMPLAINT DEVICE WAS RETURNED AND IMAGED UPON RECEIPT. A REVIEW OF THE MANUFACTURING RECORD DOES NOT INDICATE ANY INSTANCES OF REWORK OR NON-CONFORMANCE ALL (B)(4) UNITS OF THE LOT PASSED QUALITY CONTROL AND WERE RELEASED. THE DEVICE IFU STATES UNDER PRECAUTIONS, "THIS PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES STANDARD TECHNIQUES FOR PLACEMENT OF VASCULAR ACCESS SHEATHS, ANGIOGRAPHIC CATHETERS AND WIRE GUIDES SHOULD BE EMPLOYED." VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE CONFIRMS THAT THE INDY SNARE BROKE. THE SEPARATION OCCURRED AT THE DISTAL CATHETER WITHIN THE AREA WRAPPED BY THE NYLON STRING JUST PROXIMAL TO WHERE THE BRAIDED WIRES OF THE SNARE EMERGE. THE FORCE EXERTED BY THE PHYSICIAN OPERATING THE COMPLAINT DEVICE WAS SIGNIFICANT SUCH THAT THE PROXIMAL CANNULA WAS SLIGHTLY BENT AND THE CATHETER DISTAL TO THE SNARE LOOPS WAS ALSO BENT AND STRETCHED. IT IS POSSIBLE THAT THE OPERATOR EXERTED EXCESSIVE FORCE UPON THE SNARE CAUSING THE CATHETER TO BREAK. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL OF THIS EVENT.