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 Remove (1528)

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

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: pre-amendment.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 ultrathane mac-loc locking loop biliary drainage catheter was used in an unknown patient during a drainage procedure.As reported, the user stated the drainage catheter "cannot be pushed till the end on the normal inner canula (the flexible stiffener); it is possible to advance on the wire but cannot be removed; risk of breaking it." as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information clarifying the device issue has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information/correction: this complaint is being canceled.Additional information was received that indicates this event was reported in error.It was originally reported that three devices failed during three events.These three events were reported under medwatch report #1820334-2019-01961, medwatch report #1820334-2019-01960, and medwatch report #1820334-2019-01962.On (b)(6) 2019, additional information was received indicating that only two devices, same lot, failed during the same procedure on the same patient.Only one report is necessary and all additional information regarding this event will be captured under medwatch report #1820334-2019-01962.No follow up information will be submitted for this report.This complaint will be canceled by the manufacturer.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.

Event Description

See h10.

• 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: 8873692
• MDR Text Key: 154005635
• Report Number: 1820334-2019-01961
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)220611(10)9803570
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9803570
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1