MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-06 for ULTRATHANE COPE NEPHROURETEROSTOMY SET N/A ULT8.5-8.5-22-NUCL-B-RH manufactured by Cook Inc.
[169654082]
Concomitant medical products: guide wire-unknown manufacturer, 4f dilator. Pma/510(k) #: preamendment. (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
[169654083]
It was reported a male patient had bilateral ultrathane cope nephroureterostomy set tubes placed during a procedure on (b)(6) 2019. The operator reported that on (b)(6) 2019, the patient required a bilateral nephroureterostomy catheter exchange due to the tubes being "blocked up. " the upper and lower loops of the catheter were "difficult to unloop due to crud" causing the patient some pain on removal. Due to the blockage, the patient required insertion of new devices. During attempted replacement of the right nephroureterostomy catheter, the guidewire of an unknown manufacturer went through the side hole of the catheter and perforated the right ureter. A nephrostomy tube was successfully placed instead. No other adverse effects were reported for this incident. The nephroureterostomy set placed on the left side is capture under the report with manufacturer reference number (b)(4). The nephroureterostomy set placed on the right side is capture under the report with manufacturer reference number (b)(4) (this report).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-03029 |
| MDR Report Key | 9430224 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-06 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-11-08 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2019-05-06 |
| Date Added to Maude | 2019-12-06 |
| 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 | MRS. JENNIFER CANADA |
| 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 | ULTRATHANE COPE NEPHROURETEROSTOMY SET |
| Generic Name | LJE CATHETER, NEPHROSTOMY |
| Product Code | LJE |
| Date Received | 2019-12-06 |
| Returned To Mfg | 2019-11-26 |
| Model Number | N/A |
| Catalog Number | ULT8.5-8.5-22-NUCL-B-RH |
| Lot Number | 9717071 |
| 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 | 1. Required No Informationntervention | 2019-12-06 |