MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-27 for TAUT CHOLANG CATH10/BX 7.5 FR TIP X 18 20018-010 manufactured by Teleflex Medical.
[176569263]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[176569264]
It was reported that during two separate laparoscopic cholecystectomy with intraoperative cholangiograms after intubation of the duct, cholangiograms complete and the physician was removing the cholangiocath, the teleflex taut operative cholangiocath was stuck in the cystic duct. The surgeon tried numerous maneuvers to loosen the catheter and finally had to clip below and cut out the portion of the duct that contained the catheter. This is the catheter that is routinely used during this procedure by this physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2020-00180 |
| MDR Report Key | 9633359 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2018-12-10 |
| Date Added to Maude | 2020-01-27 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAUT CHOLANG CATH10/BX 7.5 FR TIP X 18 |
| Generic Name | CATHETER, CHOLANGIOGRAPHY |
| Product Code | GBZ |
| Date Received | 2020-01-27 |
| Catalog Number | 20018-010 |
| Lot Number | 73M1800259 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | MORRISVILLE NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-27 |