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 2020-01-03 for ULTRATHANE MULTIPURPOSE DRAINAGE SET N/A CLDM-10.2-MH manufactured by Cook Inc.
[178151202]
Initial reporter also sent report to fda: unknown. Pma/510(k) #: exempt. 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
[178151203]
It was reported an unknown patient required placement of an ultrathane multipurpose drainage set during a percutaneous transhepatic cholangiodrainage exchange procedure. The operator reported the drainage device was inserted in the body over the wire guide. When attempting to remove the wire from the catheter, "the wire guide got caught in the pig tail. " the wire was removed from the catheter "somehow" and "the catheter was placed in the body". As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00049 |
| MDR Report Key | 9546432 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-01-03 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-10-14 |
| Date Added to Maude | 2020-01-03 |
| 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 MULTIPURPOSE DRAINAGE SET |
| Generic Name | GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY |
| Product Code | GBO |
| Date Received | 2020-01-03 |
| Returned To Mfg | 2020-01-09 |
| Model Number | N/A |
| Catalog Number | CLDM-10.2-MH |
| Lot Number | 10039218 |
| 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 | 2020-01-03 |