MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-15 for FORMULA 418 RENAL BALLOON-EXPANDABLE STENT G56611 FOR418-18-80-6-12 manufactured by Cook Inc.
[145216212]
Common name & product code = nin stent, renal. Occupation = unknown. 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
[145216213]
As reported, during a right ventricle to pulmonary artery conduit procedure, involving a patient of unknown age and gender, a formula 418 renal balloon-expandable stent came off of the balloon inside of the patient's right ventricle. This occurred prior to attempted stent deployment. Use of the device during the procedure was described as "off label use in a pediatric patient". A cook flexor 6 french, 45cm sheath with hemostasis valve was also used during the procedure. The physician was able to retrieve the stent with a snare and a new formula stent was used to treat the patient. The procedure was prolonged by over one hour as a result of the event. A section of the device did not remain inside the patient? S body. 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 | 1820334-2019-01138 |
| MDR Report Key | 8613037 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-15 |
| Date of Report | 2019-08-29 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-08-28 |
| Device Manufacturer Date | 2019-02-04 |
| Date Added to Maude | 2019-05-15 |
| 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 | FORMULA 418 RENAL BALLOON-EXPANDABLE STENT |
| Product Code | NIN |
| Date Received | 2019-05-15 |
| Returned To Mfg | 2019-05-07 |
| Model Number | G56611 |
| Catalog Number | FOR418-18-80-6-12 |
| Lot Number | 9495011 |
| 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 | 2019-05-15 |