MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-18 for ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET N/A RUPS-100 manufactured by Cook Inc.
[136888134]
Date of event: unknown, the date of event was reported to have happened -? About a week ago?. Lot #- 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
[136888135]
It was reported a rosch-uchida transjugular liver access set was used on an unknown patient during a transjugular intrahepatic portosystemic shunt (tips) procedure. As reported the 10 french sheath was leaking from the hemostatic valve. As reported, the patient was reported to have had a "good outcome". As reported, the patient did not experience any adverse effects. Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00283 |
| MDR Report Key | 8347943 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-18 |
| Date of Report | 2019-03-06 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-02-18 |
| 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 | 2019-02-18 |
| Model Number | N/A |
| Catalog Number | RUPS-100 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-02-18 |