MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-07-31 for URETERAL DILATOR 076000 manufactured by Cook Inc.
[115596593]
(b)(6). (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
[115596594]
A transurethral dilation against the stenosis in the urinary duct was performed. Over a wire guide advanced to the target lesion, dilators contained in the ureteral dilator (076000) were pushed forward. Dilation of the lesion was begun with a thin dilator (8fr), and its diameter was sized up to larger one gradually. When the physician inserted a10fr dilator to the patient's body, resistance was encountered. Resistance was also felt in retrieving the dilator. The physician checked the retrieved dilator, noticing that the tip of it had separated and the separated segment had remained in the urinary duct. A forceps was advanced through a rigid ureteroscope and the separated dilator tip was retrieved out of the patient's body successfully. There were no adverse effects to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02347 |
| MDR Report Key | 7736138 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-07-31 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-07-23 |
| Date Mfgr Received | 2018-08-13 |
| Device Manufacturer Date | 2015-10-16 |
| Date Added to Maude | 2018-07-31 |
| 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 | URETERAL DILATOR |
| Generic Name | KOE DILATOR, URETHRAL |
| Product Code | KOE |
| Date Received | 2018-07-31 |
| Returned To Mfg | 2018-08-13 |
| Catalog Number | 076000 |
| Lot Number | 6292377 |
| Device Expiration Date | 2018-10-16 |
| 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 | 2018-07-31 |