MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-12 for ROUND TIP URETERAL CATHETER 024103 manufactured by Cook Inc.
[105764864]
This mdr is being filed after the associated complaint was reviewed under remediation protocol capa (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[105764865]
It was reported that the physicians used the round tip ureteral catheter to enter the pediatric cystoscope in order to check the ureteral orifice. The physician was unable to push the catheter forward as a result of advancement difficulty when entering the cystoscope. After several failed attempts, the physician removed the catheter and noted that it was bent and fractured. It was further noted that the catheter was bent backwards and partially severed at a sideport that was 3 cm (centimeters) from the distal tip. The physician expressed that the catheter was too soft and the material was not very good. This product problem reportedly occurred prior to patient contact and there was no impact to the patient or end user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01101 |
| MDR Report Key | 7426706 |
| Date Received | 2018-04-12 |
| Date of Report | 2018-04-12 |
| Date of Event | 2016-01-20 |
| Date Mfgr Received | 2018-04-09 |
| Device Manufacturer Date | 2015-09-03 |
| Date Added to Maude | 2018-04-12 |
| 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. 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 | ROUND TIP URETERAL CATHETER |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2018-04-12 |
| Catalog Number | 024103 |
| 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 | 2018-04-12 |