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 2020-02-20 for FORMULA 418 RENAL BALLOON-EXPANDABLE STENT G56611 FOR418-18-80-6-12 manufactured by Cook Inc.
[184138720]
Common name & product code: nin, stent, renal. Occupation: unknown. Pma/510(k) number: p100028. Device evaluated by mfg: device evaluation has begun; however, a conclusion is not yet available. 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
[184138721]
As reported, during placement of a stent within the renal artery, two formula 418 renal balloon-expandable stents came off the delivery systems. The procedure was ultimately aborted due to hemodynamic changes in the patient. There has been no report that this event caused or contributed to the hemodynamic changes. Per the initial reporter, 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. Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00406 |
| MDR Report Key | 9732368 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-20 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-11-15 |
| Date Added to Maude | 2020-02-20 |
| 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 | MRS. JENNIFER CANADA |
| 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 | 2020-02-20 |
| Returned To Mfg | 2020-02-12 |
| Model Number | G56611 |
| Catalog Number | FOR418-18-80-6-12 |
| Lot Number | 10153876 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-02-20 |