MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional procodes: fge, lje.Initial reporter occupation: unknown.Pma/510(k) #: k173035.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 placement of a 10.2 fr ultrathane mac-loc locking loop biliary drainage catheter for an internal-external biliary drainage exchange.During the procedure, the physician had difficulty advancing the catheter using a competitor's wire.When the wire was pulled back, the distal tip of the flexible stiffener was kinked.There was "considerable friction" between the wire and catheter with the wire guided directly over the catheter, which made the catheter difficult to remove.The competitor wire was not tfe coated, however the wire and catheter were "sufficiently flushed.The same issue occurred with a second, similar device.A different wire guide was used to place a catheter to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

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: d- product identifier, d4- rpn.Investigation - evaluation: on 03aug2021, cook received a complaint from (b)(4) ((b)(4) germany) stating that they had difficulty advancing and removing two ult10.2-38-40-p-32s-clb-rh [ultrathane mac-loc locking loop biliary drainage catheters] over a boston scientific.035" dream wire wire guide.The user noted significant resistance while advancing the cook catheters over the boston scientific wire guide.The user changed to an.035" amplatz wire guide and was able to finish the procedure.Reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions (mi), quality control, and specifications of the devices were conducted during the investigation.The complaint devices were not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The product¿s design history file (dhf) has controls in place to address the failure.Though a lot number was not directly provided, through an expanded sales search for this device model supplied to the user facility, two potential lots for the subject devices were able to be identified as 10113459 and 13220947.A review of the device history records (dhrs) for both potential lots revealed no recorded nonconformances related to the reported failure mode.A database search did not identify any other events associated with either lot.As there is objective evidence that the dhr was fully executed and there are no other lot-related complaints that have been received from the field, cook has concluded that the devices were manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in 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: ¿a tfe-coated wire guide must be used with ultrathane catheters.¿ 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 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.¿ based on the information provided, no product returned, and the results of our investigation, the root cause for this event has been traced to unintended use error.The customer has reported that a dream wire, manufactured by boston scientific, was used during the procedure.The supplied ifu for ult10.2-38-40-p-32s-clb-rh instructs that a tfe coated wire guide should be used with ultrathane catheters.The boston scientific dream-wire is not tfe-coated but rather has a hydrophilic coating, which likely caused difficult advancement and removal of the ult catheter.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12309083
• MDR Text Key: 267144702
• Report Number: 1820334-2021-01959
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

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 Model Number: N/A
• Device Catalogue Number: ULT10.2-38-40-P-32S-CLB-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC HC DREAM WIRE