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 2020-03-11 for ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER N/A ULT8.5-38-40-P-32S-CLB-RH manufactured by Cook Inc.
[183351256]
Age: patient is in their "late 50's". Occupation: lead tech. 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
[183351257]
It was reported a male patient required placement of an ultrathane mac-loc locking loop biliary drainage catheter for drainage of the bile duct. After the catheter was placed, leaking at the hub was noticed. The device was replaced with another device of the same lot. When the physician pulled on the string to create the pigtail loop on the catheter, the string broke. The device was replaced with a new, similar device to complete the procedure. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence. The first catheter that leaked at the hub is recorded under the medwatch report with patient identifier (b)(6) (this report). The catheter that experienced suture breakage is recorded under the medwatch report with patient identifier (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00589 |
| MDR Report Key | 9819976 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2020-02-03 |
| Date Added to Maude | 2020-03-11 |
| 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 | 2020-03-11 |
| Returned To Mfg | 2020-03-13 |
| Model Number | N/A |
| Catalog Number | ULT8.5-38-40-P-32S-CLB-RH |
| Lot Number | 10304112 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-03-11 |