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 Problems Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.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 an unknown procedure.The operator reports that "the soft stylet cannot be inserted without the aid of the hard stylet and now it sometimes feels hard to pull out of the catheter.It was also noted that when removing the soft stylet there is friction and it seems to ¿crumple.¿ the doctor stated they use the soft stylet with the rigid one and use more force to remove the stylet.It is currently unknown how many devices have experienced this failure.No other adverse events were reported.

Manufacturer Narrative

H6 - additional methods code: device not returned (4114).Investigation ¿ evaluation.It was reported that the flexible stiffener within a ultrathane mac-loc locking loop biliary drainage catheter, was difficult to insert into the catheter and remove.This incident was reported by azienda ulss 18 rovigo, in italy.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 complaint device was not returned to cook for investigation.Due to this, no dimensional, visual, or functional verifications could be completed.However, 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.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 review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot and related subassembly lots found no relevant nonconformances.A database search for complaints on the reported failure mode found one additional complaint reported for a similar failure mode, however this was from the same customer.At this time, cook could not conclude that nonconforming product from this lot exists in house or in the field.A capa has been opened to address this issue, and is currently undergoing investigation.Based on the information provided, no returned product, and the results of the investigation, a definitive cause could not be established.The appropriate personnel have been notified.Cook 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.

Event Description

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

Event Description

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

Manufacturer Narrative

Additional information - this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

• 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: 9694284
• MDR Text Key: 190692849
• Report Number: 1820334-2020-00328
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)220603(10)9781967
• 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,Followup
• Report Date: 04/21/2020

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 Expiration Date: 06/03/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9781967
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 04/06/2020; 04/13/2020
• Supplement Dates FDA Received: 04/09/2020; 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1