MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-11-06 for RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY NEEDLE N/A RMT-16-50.5-RTPS-100-10.0 manufactured by Cook Inc.
[126513576]
Pma/510(k) #: exempt. Occupation: ir tech. 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
[126513577]
It was reported a ring transjugular intrahepatic liver access and biopsy needle was used during a transjugular intrahepatic portosystemic shunt procedure. When attempting to angle the needle into the target site, the needle would not turn (no difficulty with insertion per the customer). The device was removed from the patient and the needle tip separated into the sterile field. No portion of the device remained in the patient. The procedure was completed by using another needle. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03315 |
| MDR Report Key | 8042768 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-11-06 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-10-22 |
| Date Mfgr Received | 2018-12-21 |
| Device Manufacturer Date | 2018-08-08 |
| Date Added to Maude | 2018-11-06 |
| 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 | RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY NEEDLE |
| Generic Name | GBZ CATHETER, CHOLANGIOGRAPHY |
| Product Code | GBZ |
| Date Received | 2018-11-06 |
| Returned To Mfg | 2018-11-01 |
| Model Number | N/A |
| Catalog Number | RMT-16-50.5-RTPS-100-10.0 |
| Lot Number | 9078493 |
| 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 | 2018-11-06 |