MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-28 for ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER N/A ULT10.2-38-40-P-32S-CLB-RH manufactured by Cook Inc.
[177369102]
Occupation: unknown. Initial reporter also sent report to fda: unknown. Pma/510(k) #: preamendment. 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
[177369103]
As reported, an unknown patient required the placement of an ultrathane mac-loc locking loop biliary drainage catheter for a biliary system catheter exchange. The operator reported that "the catheter did not deploy correctly. The inner stylet was getting stuck. " the operator was unable to remove the flexible stiffener. This failure was experienced on two catheters of the same lot. As reported, "one stylet broke in the catheter. " a similar device from an different lot number was utilized to successfully complete the procedure. 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 | 1820334-2020-00219 |
| MDR Report Key | 9636832 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-28 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2019-08-30 |
| Date Added to Maude | 2020-01-28 |
| 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 MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER |
| Generic Name | GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY |
| Product Code | GCA |
| Date Received | 2020-01-28 |
| Returned To Mfg | 2020-02-24 |
| Model Number | N/A |
| Catalog Number | ULT10.2-38-40-P-32S-CLB-RH |
| Lot Number | 9983647 |
| 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 | 2020-01-28 |