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

Catalog Number ULT8.5-38-40-P-32S-CLB-RH

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

Suspect medical device: biliary drain.Device available for evaluation: unknown.Occupation: unknown.Initial reporter also sent report to fda: unknown.Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown patient required placement of a biliary drain for unknown procedure.During the procedure, the operator had difficulty "getting the device over the wire." it was noted the device "just fell apart".Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Correction: this report is being sent to indicate the complaint event is not reportable.Upon further investigation regarding the failure mode, this event is not reportable.It was previously thought the flexible stiffener was difficult to remove, but investigation has concluded that the failure mode is difficulty advancing the stiffener.A review of risk documentation does not indicate that this event is likely to cause serious injury if it were to reoccur.As there are no recorded incidences of serious injury due to the complaint event, and it is not likely that serious injury would result if the event were to recur, per 21cfr part 803.50 the complaint event is considered not reportable.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Event Description

Additional information provided 13mar2020 clarified that the failure was that the plastic stiffener got stuck towards the proximal end of the drain.The physician also stated that the wire would not go through the drain easily.Nothing "fell apart" and no separation occurred.The catheter was removed and replaced with another biliary drain.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 9848696
• MDR Text Key: 184121234
• Report Number: 1820334-2020-00642
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MANUFACTURER 035 AMPLATZ