MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2018-09-05 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS FUS-107035 manufactured by Cook Inc.
[119662039]
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119662040]
It was reported during ureteroscopy, the cook ureteral sheath frayed, leaving a shred of plastic in the urinary tract during ureteroscopy/stone removal. Being that the shred was so small, several graspers did not work. The foreign body was finally removed prior to completion of procedure. Procedure was reported to be: stone removal. The patient's status/outcome was not provided in the report. Requests have been made for the following additional information. Date of event: mm/dd/yyyy. Relevant patient health history, including pre-existing conditions (size, location of stone, ca, tortuous anatomy, etc. ): is the device still available for return to the manufacturer for analysis? Are there any videos, images, pictures or operative reports that can be provided for review? Please list other devices in use prior to and at the time of the reported ureteral sheath fraying: were there any difficulties experienced during insertion or removal of devices? If so, please describe the issues: can you describe how the? Shred of plastic? Was finally retrieved from the patient? S urinary tract? Did the patient experience any adverse effect(s) due to this event? If yes, did the device cause or contribute to the adverse effect(s)? At the time of this report, the facility representative has not responded to our requests for additional information, patient outcome or the status of device availability for manufacturer analysis to be performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02611 |
| MDR Report Key | 7847533 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2018-09-05 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2018-10-19 |
| Date Added to Maude | 2018-09-05 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | FLEXOR URETERAL ACCESS SHEATH AND DILATORS |
| Generic Name | KOE DILATOR, URETHRAL |
| Product Code | KOE |
| Date Received | 2018-09-05 |
| Catalog Number | FUS-107035 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-09-05 |