MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The international customer reported that the stylet could not be inserted into the ultrathane mac-loc locking loop biliary drainage catheter.There was reportedly no patient contact; accordingly, no patient adverse events occurred.Another catheter was selected instead, with no further issues reported.The product has been received for evaluation; however, as of the date of this report, the investigation is still pending.

Manufacturer Narrative

Investigation - evaluation: a review of the drawings, dimensional verification, device history record, complaint history, documentation, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.No systemic issues were found related to the reported complaint.One ultrathane mac-loc locking loop biliary drainage catheter was returned in an opened and prepped condition.Prior to investigation, the blue flexible stiffener was partially inserted into the catheter.Approximately 9.0cm of the flexible stiffener was protruding from the proximal end of the catheter.Upon removal of the flexible stiffener, damage to the shaft was confirmed, measuring from the hub at approximately 10.0cm, 10.3cm, 10.8cm, and 17.3cm.Complete reinsertion of the blue flexible stiffener was not possible.A visual examination of the catheter shaft did not detect damage.The diameter of the flexible stiffener, the french size of the catheter, and the outer diameter of the catheter were all measured to be within specifications.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of the device history record revealed one non-conformance for lot 6739989 for foreign matter and is not related to this event.In addition, there were no other reported complaints for this lot number.Photos, operating reports, x-rays, and scans were requested; but the reporter indicated that no such material will be provided.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.However, it is possible that the device was damaged during shipping and handling.Other possible contributing factors include damage when opening the device or preparing it for use.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7009671
• MDR Text Key: 92486354
• Report Number: 1820334-2017-03803
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)190216(10)6739989
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1