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 |