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 10/23/2017

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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: evaluation of the returned device has been completed.Preamendment.Investigation - evaluation a review of the drawings, dimensional verification, device history record, complaint history, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The catheter was returned in a used condition.During the investigation, it was observed that the flexible stiffener was partially inserted into the catheter.The extension of the flexible stylet from the proximal end of the catheter measured approximately 7.1cm.The attempt to advance the flexible stiffener was unsuccessful.Upon removing the flexible stiffener a kink was noted in the shaft of the stiffener at approximately 7.5cm measuring from the proximal end of the hub.Measuring the outer diameter, it was observed that the tubing was out of round, indicating that the material was damaged, causing the difficulty in advancement.Measurements of the shaft of the catheter in several locations, the outer diameter of the catheter, as well as the diameter of the flexible stiffener all indicated that such dimensions are within cook's manufacturing 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 shows one non-conformance for lot 6819644 in which a proximal end was not manufactured to specification and was scrapped.This non-conformance is not related to this event.In addition, there were no other reported complaints for this lot number.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
• MDR Report Key: 7009788
• MDR Text Key: 92489712
• Report Number: 1820334-2017-03802
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)190317(10)6819644
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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
• Date Manufacturer Received: 01/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1