MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-05-29 for INDY OTW VASCULAR RETRIEVER N/A INDY-8.0-35-55-40 manufactured by Cook Inc.
[22248280]
During a aaa+zbis procedure on an (b)(6) male patient, the vascular retriever broke 3 centimeters before the distal tip after capture of the hydrophillic wire guide. An attempt was made to retrieve the separated portion with a flexor 12 fr; however, the tip and snares remained in the femoral artery. All were immediately retrieved with a fogarty device without harm to the patient. 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
[22277960]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34462589]
(b)(4). Event evaluation: a review of complaint history, device history record, documentation, and quality control was conducted during the investigation. The product was not returned for evaluation. The device history record was reviewed. Other documentation regarding the manufacture of this device was reviewed. There is no evidence to suggest that the product was not manufactured to the correct specifications. Without additional information or the complaint device, no conclusion can be drawn for the cause of this complaint. Based on quality engineering risk assessment, no additional actions are required at this time. The appropriate internal personnel will be notified and we will continue to monitor for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[34462590]
During a aaa+zbis procedure on an (b)(6) year old male patient, the vascular retriever broke 3 centimeters before the distal tip after capture of the hydrophilic wire guide. An attempt was made to retrieve the separated portion with a flexor 12 fr; however, the tip and snares remained in the femoral artery. All were immediately retrieved with a fogarty device without harm to the patient. 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 | 1820334-2015-00336 |
| MDR Report Key | 4811818 |
| Report Source | 01,08 |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-03 |
| Date of Event | 2015-04-28 |
| Date Facility Aware | 2015-04-28 |
| Report Date | 2015-05-03 |
| Date Mfgr Received | 2015-05-07 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2015-06-03 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDY OTW VASCULAR RETRIEVER |
| Generic Name | GAE SNARE, SURGICAL |
| Product Code | GAE |
| Date Received | 2015-05-29 |
| Model Number | N/A |
| Catalog Number | INDY-8.0-35-55-40 |
| Lot Number | 4927862 |
| ID Number | SEE FIELD H10 |
| Device Expiration Date | 2017-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-05-29 |