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 2019-05-21 for FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS UNKNOWN manufactured by Cook Inc.
[145683753]
Common name/pro code: exact rpn unknown-either fed (endoscopic access overtube, gastroenterology-urology) or koe; ezn (endoscopic access overtube, gastroenterology-urology; dilator, catheter, ureteral). Pma/510k # : exact rpn unknown-either k043418 or k961904. (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
[145683754]
It was reported during a ureteroscopy on a (b)(6) male (with a pre-existing stent) using a flexor parallel ureteral access sheath, the physician placed a guide wire up to the kidney, then placed the access sheath "once physician removed obturator the access sheath popped out of the patient". The physician went back into the bladder but couldn't get back up to the kidney again. It was then observed that they had everted the ureteral orifice. The physician stated that they might have caught the lip of the sheath on the ureteral orifice contributing to this issue. It is unknown how the procedure was completed after this difficulty was experienced. It was reported that the physician was considering at ct scan to assess for damage to the ureter, at the time of the report, this had not yet been completed. No other consequences to the patient have been reported as a result of this alleged product malfunction. Additional details regarding the patient and the event has been requested. At this time, no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01168 |
| MDR Report Key | 8628326 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-21 |
| Date of Report | 2019-06-12 |
| Date of Event | 2019-05-04 |
| Date Mfgr Received | 2019-05-22 |
| Date Added to Maude | 2019-05-21 |
| 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 | FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS |
| Product Code | EZN |
| Date Received | 2019-05-21 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Other | 2019-05-21 |