MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-06-18 for FORMULA 418 RENAL BALLOON-EXPANDABLE STENT G56610 FOR418-18-80-5-20 manufactured by Cook Inc.
[148302579]
Common name & product code = nin, stent, renal. Occupation = lab manager. Pma/510(k) number = p100028. (b)(4). 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
[148302580]
As reported, during a procedure to treat renal artery stenosis involving a male patient of unknown age, a formula 418 renal balloon-expandable stent balloon ruptured, displacing the stent. The physician reportedly advanced the stent into the renal artery and believes that the catheter of the balloon was cut by the patient's calcium. The balloon and stent were advanced into the intended location; however, the punctured balloon would not inflate. The physician then attempted to remove the entire device when the stent became dislocated off the delivery catheter outside of the planned location. Attempts to retrieve the stent with a snare were unsuccessful. The physician was able to move the stent to a location that would not cause any issues and the stent remains in the patient's leg. There are no plans to retrieve the stent. There have been no reported adverse effects to the patient as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01470 |
| MDR Report Key | 8707908 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-06-18 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-06-12 |
| Date Mfgr Received | 2019-08-21 |
| Device Manufacturer Date | 2019-01-02 |
| Date Added to Maude | 2019-06-18 |
| 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 | FORMULA 418 RENAL BALLOON-EXPANDABLE STENT |
| Product Code | NIN |
| Date Received | 2019-06-18 |
| Model Number | G56610 |
| Catalog Number | FOR418-18-80-5-20 |
| Lot Number | 9415254 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other; 2. Required No Informationntervention | 2019-06-18 |