MAUDE Adverse Event Report: TELEFLEX TAUT CHOLANG CATH10/BX 4.5 FR TIP X 30; CHOLANGIOGRAM CATHETER

Catalog Number 18400

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2014

Event Type  malfunction  

Event Description

Complaint alleges: the metal support tube was missing from the catheter.The catheter was threaded in the cystic duct.The surgeon put a clip on the catheter to hold it in place during the procedure.The clip cut through the catheter.The surgeon caught it before it fell into the patient.There was no patient injury and the patient's current condition is fine.

Manufacturer Narrative

A device history record (dhr) review the operator omitted the crimping operation and dhr review did confirm defect reported by customer "metal support tube missing".The sample was not received at the time of this report.If the sample or additional information is received, a follow-up report will be sent.

• Brand Name: TAUT CHOLANG CATH10/BX 4.5 FR TIP X 30
• Type of Device: CHOLANGIOGRAM CATHETER
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer Contact: doris sturgis, (cas) ; p.o box 12600; prolongacion mision eusebio; rtp, NC 27709 ; 9194334953
• MDR Report Key: 3757183
• MDR Text Key: 4553072
• Report Number: 3003898360-2014-00147
• Device Sequence Number: 1
• Product Code: GBZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 18400
• Device Lot Number: 01A1400037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1