MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-12 for FORMULA 414 RX BALLOON-EXPANDABLE STENT FOVX414-14-135-4-16 manufactured by William Cook Europe.
[182985337]
Manufacturer ref# (b)(4). Common device name: nin? Renal balloon-expandable stent. Similar to device under pma/510(k) p100028. Investigation is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[182985338]
Description of event according to initial reporter: stent came loose together with the covering protective tube and could no longer be used. Prior to use the protection tube of the stent had been removed. After getting the delivery system to the right place physician wanted to inflate the balloon and expand the stent. By doing this he realised that the stent was not there and the balloon inflated without a stent. Not knowing where the stent had been lost and being afraid it might be somewhere intracorporal physician searched all the vascular way from entry point to stenting area via x-ray. Just by accident a nurse found the stent still sticking in the protection tube which has been put beside. The stent was showing out just a few mm out of the tube. Then a second stent was opened and placed successfully. Patient outcome: 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 | 3002808486-2019-01464 |
| MDR Report Key | 9004111 |
| Date Received | 2019-09-12 |
| Date of Report | 2019-09-12 |
| Date of Event | 2019-08-20 |
| Date Mfgr Received | 2019-08-20 |
| Device Manufacturer Date | 2016-10-25 |
| Date Added to Maude | 2019-09-12 |
| 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. THOMAS HESSNER KIRK |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-4632 |
| Manufacturer Phone | 56868686 |
| Manufacturer G1 | WILLIAM COOK EUROPE |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-4632 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FORMULA 414 RX BALLOON-EXPANDABLE STENT |
| Product Code | NIN |
| Date Received | 2019-09-12 |
| Returned To Mfg | 2019-09-03 |
| Catalog Number | FOVX414-14-135-4-16 |
| Lot Number | E3510096 |
| Device Expiration Date | 2019-10-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM COOK EUROPE |
| Manufacturer Address | SANDET 6 BJAEVERSKOV 4632 DA 4632 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-12 |