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 2018-10-09 for ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET N/A RUPS-100 manufactured by Cook Inc.
[123057673]
Pma/510(k) #: exempt. (b)(4). 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
[123057674]
It was reported a rosch-uchida transjugular liver access set was used for a transjugular intrahepatic portosystemic shunt procedure. During the procedure, the cannula was inserted and would not make the turn into the hepatic vein, causing the tip of the sheath to break off. The sheath then began to unravel. The fractured tip was retrieved with a foreign body retrieval and the procedure was abandoned. No other adverse effects have been reported. Additionally, the device is not available for return, it was thrown away once it was removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
[129964715]
Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control of the device was conducted during the investigation. The complaint device was not returned; therefore, no physical examinations could be performed. However, a document based investigation evaluation was performed. There are sufficient controls in place to detect the separated sheath tip failure mode prior to release to the customer. A review of the device history record was conducted and revealed two unrelated nonconformances for proximal ends that were cut at the wrong length and leakage. All of these devices were scrapped. Two more nonconformances were found in the kcfw lot for split distal tips and split flares, of which all affected devices were scrapped. No relevant nonconformances were found in the rups-100 that could have contributed to the reported failure mode. It should be noted that there were no other complaints reported for these lot numbers. The instructions for use (ifu) note that the device is intended for one time use and is sterile if the package is unopened or undamaged. The product should not be used if there is any doubt about its sterility. The product should be stored in a dark, dry and cool place and exposure to extended periods of light should be avoided. The user is advised to inspect the product prior to use to ensure that no damage has occurred. A review of the supplier production and inspection records were requested, and from the supplier investigation, the production and inspection records of the complaint lot did not identify any abnormal issues while producing the lot. A review of equipment maintenance, along with the calibration records, showed everything to be in compliance with establishment protocol. The supplier could not identify a definitive cause but will audit their process to ensure the continuous conformance of the product. Based on the information provided, no returned product and the results of our investigation, a definitive root cause could not be established. It is possible that the cause can be traced to the user. If the physician twists the needle inside of the sheath, the needle may puncture the sheath, causing the unraveling although this could not be confirmed. The appropriate personnel have been notified. Per the quality engineering risk assessment no further action is required. Cook will continue to monitor for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[129964716]
No new event description information to report at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02289 |
| MDR Report Key | 7946543 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-09 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2018-02-15 |
| Date Added to Maude | 2018-10-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-10-09 |
| Model Number | N/A |
| Catalog Number | RUPS-100 |
| Lot Number | 8591925 |
| 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 | 1. Other; 2. Required No Informationntervention | 2018-10-09 |