MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2018-09-28 for ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET N/A RUPS-100 manufactured by Cook Inc.
[122646484]
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
[122646485]
It was reported that during a transjugular intrahepatic portosystemic shunt (tips) procedure, during puncture, the valve separated from the sheath of a rosch-uchida transjugular liver access set. As a result, the user removed the damaged sheath and a new device was used to finish the procedure. Per the customer, no resistance was encountered while advancing the sheath. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence.? According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02867 |
| MDR Report Key | 7918344 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2018-09-28 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2018-03-06 |
| Date Added to Maude | 2018-09-28 |
| 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 | 2018-09-28 |
| Returned To Mfg | 2018-10-01 |
| Model Number | N/A |
| Catalog Number | RUPS-100 |
| Lot Number | 8644659 |
| 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 | 2018-09-28 |