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 Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 the patient returned on (b)(6) 2018 due to leaking of the ultrathane mac-loc locking loop biliary drainage catheter.The drainage catheter was initially placed on (b)(6) 2018 for a biliary drain procedure.The device was successfully replaced with a similar device from a different lot.As reported, the patient did not experience any adverse events due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: additional information received on 11sep2018 noted that the access site was the right sided biliary tract for a drain exchange.When the patient returned for a device replacement, it was noticed that the hub of the defective device was cracked.Pre-existing conditions of the patient included hypothyroidism, cll, multiple myeloma and pe.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

Additional information: additional information received on (b)(6) 2018 noted that the access site was the right sided biliary tract for a drain exchange.When the patient returned for a device replacement, it was noticed that the hub of the defective device was cracked.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation - evaluation a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, as well as a functional test, visual inspection and dimensional verification of the returned device was conducted during the investigation.One locked 14.0fr mac-loc catheter in used condition was returned for investigation.The device was returned in two separate pieces with biomatter present on the device.The first piece was comprised of a purple adapter hub, the mac-loc hub and connector cap, while the second piece was comprised of approximately 47cm of catheter tubing from the flare to the distal pigtail curl.Nine additional crude holes were noted proximal to the radiopaque band, most likely made by the customer.Tug and twist tests revealed that the proximal assembly was secure.Upon removal of the cap, the suture string was found heavily wound in the threads.The flare appeared dented on one side causing it to be out of round, but due to the compression of the flare within the cap and the potential for damage upon removal, it cannot be determined if the flare was manufactured to specifications.Due to the congealed biological matter and visible tampering of the catheter tubing, the tubing outer diameter was unable to be accurately measured.Other relevant measurements were all found to be within manufacturer specifications.Additionally, a document based investigation evaluation was performed and based on the documentation, inspection activities are in place to prevent the release of nonconforming product related to the reported failure mode.A review of the device history record showed one nonconformance for too many adapter threads, of which seven affected devices were scrapped.It should be noted that no other complaints associated with this lot number.Based on the information provided, the examination of the returned product and the results of our investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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: 7796661
• MDR Text Key: 117569461
• Report Number: 1820334-2018-02540
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002095007
• UDI-Public: (01)00827002095007(17)210524(10)8907168
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT14.0-38-40-P-32S-CLB-RH
• Device Lot Number: 8907168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 09/11/2018; 10/31/2018
• Supplement Dates FDA Received: 10/09/2018; 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention