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 2019-02-14 for ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET N/A RUPS-100 manufactured by Cook Inc.
[136295457]
Concomitant medical products: terumo sheath, johnson & johnson balloon, gore viatorr stent. Occupation: agent. 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
[136295458]
It was reported an rosch-uchida transjugular liver access set was used in a male patient with cirrhosis of the liver and portal hypertension. As reported, during the advancement of the sheath, the proximal end was detached from the check-flo assembly valve. The operator removed the damaged sheath and was able to complete the procedure successfully with a new rosch-uchida transjugular liver access set. The complaint device was archived at the manufacturer to aid in the investigation. Excessive biomatter was present all over the device and the check-flo assembly was confirmed to be detached from the sheath. Other than the check-flo assembly detachment, no other damage was noted to the device. The inner coiling of the device was noted to be unraveled at the proximal end where the separation occurred. A portion of the sheath tubing was found within the hub. 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 | 1820334-2019-00180 |
| MDR Report Key | 8338706 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-14 |
| Date of Report | 2019-03-05 |
| Date of Event | 2019-01-30 |
| Date Mfgr Received | 2019-03-04 |
| Device Manufacturer Date | 2018-11-27 |
| Date Added to Maude | 2019-02-14 |
| 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 | ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET |
| Generic Name | GBZ CATHETER, CHOLANGIOGRAPHY |
| Product Code | GBZ |
| Date Received | 2019-02-14 |
| Returned To Mfg | 2019-02-07 |
| Model Number | N/A |
| Catalog Number | RUPS-100 |
| Lot Number | 9335751 |
| 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 | 2019-02-14 |