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

Date of event: event occurred sometime in (b)(6) 2020.(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

H6 ¿ method code: (4114) device not returned.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 (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 were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.Therefore, no visual inspection of the device was completed.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) could not be reviewed.The customer did not provide a lot number for investigation.A search of all lots sold to the customer for the reported rpn in the past three years found five potential lots.The dhr's for the lots and relevant tubing subassembly's revealed relevant non-conformances.However, all nonconforming product was scrapped, and the devices go through a 100% inspection for the reported nonconformances.A database search for complaints on the list of potential lots found two additional complaints on the lot.Only one complaint is related for a metal stiffener difficult advancement.Due to not knowing the lot, 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, no returned product, and results of the investigation, a definitive cause could not be established.Appropriate measures are being conducted 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

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 parkview community 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 were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.Therefore, no visual inspection of the device was completed.However, 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 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.¿ the customer did not provide a lot number for investigation.A search of all lots sold to the customer for the reported product in the past three years found five potential lots.The device history records for the lots and relevant tubing subassembly lots revealed two relevant non-conformances.However, all nonconforming product was scrapped, and the devices go through a 100% inspection for the reported nonconformances.A database search found two additional complaints, both of which were reported by the same customer on the same day.From the information provided upon review of documentation, device history record, and instructions for use, cook could not conclude that the device was manufactured out of specification, or that there are nonconforming devices in house or out in the field.A capa has been opened to address this issue and is currently undergoing investigation.Based on the limited information provided, no returned product, and results of the investigation, a definitive root 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: 9717139
• MDR Text Key: 201057104
• Report Number: 1820334-2020-00372
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 03/27/2020; 04/10/2020
• Supplement Dates FDA Received: 04/08/2020; 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1