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 Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510(k) #: not exempt.Pma/510(k) #: authorization number: preamendment.(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 that an ultrathane mac-loc locking loop biliary drainage catheter was placed into a patient during a ptgbd procedure.During drainage, it was noted that there was no air pressure within the catheter and air was leaking from the hub.The user removed the leaking catheter and replaced it successfully with a like device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

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.Additional information: d10 - product received on: 23 august 2018.Investigation - evaluation: a review of the documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, as well as a functional test, dimensional verification and a visual inspection of the returned device were conducted during the investigation.Two 8.5fr mac-loc catheters were returned for evaluation.The first catheter was returned in a locked position as two separate pieces.The first piece was comprised of the mac-loc hub, connector cap and approximately 19cm of tubing ending in a separation.The second piece consisted of approximately 27cm of tubing beginning with the separation and ending with the distal pigtail.Biological matter was present on the device and no other surface damage was noted.A leak test was conducted and confirmed the presence of a leak between that catheter tubing and connector cap.Tug and twist tests revealed that the proximal assembly was secure.Upon removal of the connector cap, the suture string was found to be wound in the threads.The flare appeared slightly lopsided, but due to the compression of the flare within cap and the potential for damage upon removal, it cannot be determined if the flare was manufactured to specifications.Dimensional analysis confirmed that the device had been manufactured to the correct specifications and tolerances, but on physical examination, it was noted that the number of threads showing on the device exceeded what was detailed in the manufacturer¿s instructions.The device was deemed to be out of specification.The second catheter was returned in an unused condition.No biological matter was present on the device with no additional surface damage noted.A leak test was conducted and confirmed the presence of a leak between that catheter tubing and connector cap.Tug and twist tests revealed that the proximal assembly was secure.Upon removal of the connector cap, the suture string was found to be wound in the threads.The flare appeared slightly lopsided, but due to the compression of the flare within the cap and the potential for damage upon removal, it cannot be confirmed if the flare was manufactured to specifications.Dimensional analysis confirmed that the device had been manufactured to the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The instructions for use (ifu) instruct the user to inspect the device prior to use to ensure that no damage has occurred.A review of the device history record could not be conducted as the lot number is unknown.Based on the information provided, the examination of the returned product and the results of our investigation, a definitive cause could not be established.It is possible that the cause could be manufacturing related.Potential factors that may have contributed to the cause include suture presence in the threads of the cap/adapter assembly causing interference with the seal during torqueing, and inconsistent flaring process and the silicone insert being punctured from improper threading technique.Appropriate measures have been taken to address this failure mode.The appropriate personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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: 7804307
• MDR Text Key: 117836298
• Report Number: 1820334-2018-02224
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 10/24/2018
• Supplement Dates FDA Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO WIRE, SUNGWON SHEATH, NEEDLE, 018 HAIR WIRE; TERUMO WIRE, SUNGWON SHEATH, NEEDLE, 018 HAIR WIRE