MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-15 for INDY OTW VASCULAR RETRIEVER G51835 INDY-8.0-35-55-40 manufactured by Cook Inc.
[142039182]
(b)(6). Concomitant medical products: 20fr sheath + guidewire. Pma/510(k) #: k160593. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[142039183]
It was reported during a fenestrated endovascular aortic/aneurysm repair (fevar)with an iliac branch device (ibd), the indy snare was placed up the patient? S left femoral through a 20fr sheath and had snared a guidewire (0. 035? ). The snare was pulled back into the sheath the snare the wire. In the process of removing the snare from the patient, it snapped. The snare did not separate. To ensure that it sis not separate forceps were placed proximal to the "snapped" area and clamped on the wire to retrieve the snare and wire. There was no significant tortuosity or calcification in the patient's vessels. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00522 |
| MDR Report Key | 8516235 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-15 |
| Date of Report | 2019-10-09 |
| Date of Event | 2019-03-29 |
| Date Mfgr Received | 2019-10-02 |
| Device Manufacturer Date | 2019-01-22 |
| Date Added to Maude | 2019-04-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDY OTW VASCULAR RETRIEVER |
| Generic Name | MMX DEVICE, PERCUTANEOUS RETRIEVAL |
| Product Code | MMX |
| Date Received | 2019-04-15 |
| Returned To Mfg | 2019-04-11 |
| Model Number | G51835 |
| Catalog Number | INDY-8.0-35-55-40 |
| Lot Number | 9464231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-15 |