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 Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(6).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 the placement of an ultrathane mac-loc locking loop biliary drainage catheter for a biliary drainage procedure.The operator reported "the inner metal and plastic stylets would not release to form the pigtail." as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

D10 ¿ product received on: 21feb2020.Investigation ¿ evaluation: it was reported that the metal stiffener within a ultrathane mac-loc locking loop biliary drainage catheter could not be removed from the catheter.This incident was reported by parkview community hospital, in the united states.No adverse effects to the patient were reported.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, and dimensional verification, were conducted during the investigation.The complainant returned one catheter for investigation.No stiffener was returned with the catheter.Light biomatter was noted on the distal tip, however no damage was noted to the device.All dimensions deemed relevant to the reported failure were measured and confirmed that the device was manufactured within specification.Additionally, a document-based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) for the device lot and relevant subassemblies revealed one relevant nonconformance, however all nonconforming product was scrapped, and the device goes through a 100% inspection for the nonconformance.A database search revealed one additional complaint has been reported for the device lot, however this complaint was on the same device but a different component.Due to the above information, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.The ifu supplied with mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.A capa is currently open to address metal stiffener advancement and removal difficulty.Based on the information provided, visual inspection of returned device, and results of the investigation, a definitive cause could not be established.Appropriate measures are being conducted have been taken to address this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook 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.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: h6- ec method code 1.Investigation ¿ evaluation: it was reported that both the metal stiffener and the flexible stiffener within a ultrathane mac-loc locking loop biliary drainage catheter could not be removed from the catheter.This incident was reported by (b)(6) hospital in the united states.No adverse effects were reported.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.The complainant returned one catheter for investigation.No stiffener was returned with the catheter.Light biomatter was noted on the distal tip, however no damage was noted to the device.All dimensions deemed relevant to the reported failure were measured and confirmed that the device was manufactured within specification.Additionally, a document-based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) for the device lot and related subassemblies revealed relevant nonconformances for ¿i.D.Incorrect," however all nonconforming product was scrapped, and the device goes through a 100% inspection for the nonconformance.A database search revealed one additional complaint has been reported for the device lot, however this complaint was on the same device from the same customer, opened for trending.Due to the above information, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: precautions: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not upset he product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ a capa has been opened to address this issue and is currently undergoing investigation.Based on the information provided, evaluation of returned product, and results of the investigation, a definitive cause could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook 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.

Event Description

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

• 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: 9717172
• MDR Text Key: 201057974
• Report Number: 1820334-2020-00374
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)221024(10)10105173
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 10105173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1