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 Material Separation (1562)

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

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Age: patient is in their "late 50's".Occupation: lead tech.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 a male patient required placement of an ultrathane mac-loc locking loop biliary drainage catheter for drainage of the bile duct.After the catheter was placed, leaking at the hub was noticed.The device was replaced with another device of the same lot.When the physician pulled on the string to create the pigtail loop on the catheter, the string broke.The device was replaced with a new, similar device to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The first catheter that leaked at the hub is recorded under the medwatch report with patient identifier (b)(6).The catheter that experienced suture breakage is recorded under the medwatch report with patient identifier (b)(6) (this report).

Manufacturer Narrative

D10- concomitant medical product available for return: no.H6 ¿ method code: (4114) device not returned.Investigation ¿ evaluation.Dmg interventional radiology informed cook of an incident involving a ultrathane mac-loc locking loop biliary drainage catheter.During a billiary drain insertion procedure the device was successfully placed in the patient when they noticed the catheter was leaking at the hub (reported under medwatch report #1820334-2020-00589).The facility exchanged the catheter for a new catheter from the same lot number.When the physician was pulling on the string to create a pigtail loop the string broke (this reported).The facility did not use excessive force when pulling the string.No unintended section of the device remained inside the patient¿s body, the patient did not require additional procedures due to this occurrence and there have been no adverse effects to the patient due to this occurrence.A review of the complaint history, device history record, instructions for use (ifu), 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 performed.Additionally, a document-based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.All tested devices met the acceptance criterion for the peak tensile load prior to failure of the suture of the catheter.The device history record (dhr) was reviewed.The final lot and raw material lot revealed no non-conformances.A complaint database search was completed and one additional complaint was found for this lot.The complaint was reported from the same user facility for the same procedure on the same patient for a different failure mode of ¿leaking where the catheter and hub connect.¿ at this time, cook could not conclude that nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The product ifu, [t_multi_rev5] ¿multipurpose drainage catheter,¿ provides the following information to the user related to the reported failure mode: precautions: ¿traction on the locking suture, if present, should be sufficient to ensure adequate retention of the tip, but should not be overly tight.¿ instuctions for use: mac-loc locking loop mechanism: a.¿stabilize the mac-loc catheter hub assembly with one hand and pull back on the drawstring to form the distal catheter loop configuration.B.While maintaining traction on the drawstring, push the locking cam lever down until a distinct ¿snap¿ is felt.The distal loop of the catheter is now locked in position.How supplied: ¿supplied sterilized by ethylene oxide gas in peel-open package.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the 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.¿ findings of this investigation revealed no evidence to suggest the device was manufactured out of specification.Based on the information provided, no returned product, and results of the investigation, it was concluded that the cause was traced to component failure without a manufacturing or design deficiency.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: 9836766
• MDR Text Key: 183740804
• Report Number: 1820334-2020-00623
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)230203(10)10304112
• 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
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 10304112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1