MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2019-05-21 for UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER G55804 ULCS-14-30 manufactured by Cook Inc.
[146369811]
(b)(6). Pma/510k #: k140085. 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
[146369812]
It is reported during a procedure to place a "percutaneous drain of the abdomen with the use of a nephrostomy set" using a universa loop nephrostomy percutaneous drainage catheter, "the guide wire was faulty. " "the guide wire was inserted into the abdomen, dilators were then used and once the pigtail was inserted, the guide wire was then pulled back and during that process that is when we realized it was untangling. " it was not possible to insert the guide wire into the abdomen again. "everything else in the nephrostomy set was alright, however the guide wire was faulty" it is not known how the procedure was completed after the difficulty. There were no adverse effects to the patient as a result of this alleged product malfunction. The patient did not require any additional procedures as a result of this occurrence. Additional details regarding the patient and the event have been requested. At this time, no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01169 |
| MDR Report Key | 8629107 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2019-05-21 |
| Date of Report | 2019-07-30 |
| Date of Event | 2019-04-24 |
| Date Mfgr Received | 2019-07-04 |
| Device Manufacturer Date | 2018-10-25 |
| 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 | UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2019-05-21 |
| Returned To Mfg | 2019-06-10 |
| Model Number | G55804 |
| Catalog Number | ULCS-14-30 |
| Lot Number | 9261777 |
| 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 | 2019-05-21 |