MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-10 for FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS FUS-120055-P manufactured by Cook Inc.
[105411058]
The complainant reported that the procedure being performed was "kidney stone flex urs. " this mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed. Blank fields on this form that have not been previously submitted indicate the information is unknown or unavailable.
Patient Sequence No: 1, Text Type: N, H10
[105411059]
The complainant reported that the flexor parallel ureteral access sheath was in position and when the dilator was removed, the wire was released on the tip for remaining access in the working channel. The wire was curled up spirally during the procedure, so working channel access was no longer possible. It was further noted that an unidentified wire was uncoiled. There were no reported serious injuries to the patient as a result of the reported product problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01086 |
| MDR Report Key | 7419335 |
| Date Received | 2018-04-10 |
| Date of Report | 2018-04-10 |
| Date of Event | 2015-01-05 |
| Date Mfgr Received | 2018-04-09 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2018-04-10 |
| 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 | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS |
| Generic Name | KOE DILATOR, URETHRAL |
| Product Code | KOE |
| Date Received | 2018-04-10 |
| Catalog Number | FUS-120055-P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-04-10 |