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.
[136889719]
Date of event: unknown. As reported, the event occurred,? 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
[136889720]
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. According to the report, the patient experienced a "good outcome". As reported, the patient did not experience any adverse effects nor did the patient require any additional procedures due to this event. 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 | 1820334-2019-00282 |
| MDR Report Key | 8347903 |
| 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 |