TAUT CHOLANG CATH10/BX 7.5 FR TIP X 18 20018-010

MAUDE Adverse Event Report

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.

Event Text Entries

[176463785] (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


[176463786] 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


MAUDE Entry Details

Report Number3003898360-2020-00181
MDR Report Key9633370
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-01-27
Date of Report2020-01-24
Date of Event2020-01-23
Date Mfgr Received2020-01-30
Device Manufacturer Date2018-12-10
Date Added to Maude2020-01-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJASMINE BROWN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9193614124
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetRANCHO EL DESCANSO
Manufacturer CityTECATE 21478
Manufacturer CountryMX
Manufacturer Postal Code21478
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTAUT CHOLANG CATH10/BX 7.5 FR TIP X 18
Generic NameCATHETER, CHOLANGIOGRAPHY
Product CodeGBZ
Date Received2020-01-27
Catalog Number20018-010
Lot Number73M1800259
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressMORRISVILLE NC


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-27

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