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

Model Number N/A

Device Problem Obstruction of Flow (2423)

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

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation - occupation: unknown.Pma/510(k) #: exempt.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 that an ultrathane mac-loc locking loop multipurpose drainage catheter became obstructed while implanted in the patient.On (b)(6) 2022, it was discovered that bilateral nephrostomy tubes that had been placed in the patient were compromised.During a routine injection of saline, the physician stated that the 10.2fr multipurpose catheter placed three days prior, seemed to be obstructed and proceeded to advance due to an increase in indwelling pressure.The catheter would not drain effectively, with the backflow causing contents to spill and leakage to increase.A device from another manufacturer was used to replace the occluded device in an additional procedure.The patient was reported to be "ok" proceeding the secondary intervention.Additional information regarding patient and event details have been requested, but is currently unavailable.Another event capturing the additional nephrostomy tube occlusion and replacement can be found in the report with the patient identifier: (b)(6).

Event Description

In additional information received on 25jan2022, it was reported that there was percutaneous placement of the device in the kidney area over a stiff wire guide.The patient did not experience hospitalization or prolonged hospitalization due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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.

Event Description

The device was returned for investigation on 25mar2022.One used device was received with the hub cut off and material elongation was noted in the tubing.No obstruction was noted, however, a ballooned area was noted at approximately 11cm from the distal end.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported by (b)(6) of (b)(6) medical center, that on (b)(6) 2022 an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult10.2-38-25-p-6s-clm-rh, lot# 13931337) occluded.The device was required for a nephrostomy drain in a 63-year-old male patient and was placed in the kidney percutaneously over a stiff wire guide.Three weeks after placement, during a routine saline injection, the physician noted the catheter seemed obstructed; the device was not draining effectively and was leaking.The physician also noted the catheter had advanced further into the patient due to the increased indwelling pressure.As a result, the patient required an additional procedure to replace the device with a competitor¿s product.It was noted that at the time of device exchange, the patient had bilateral nephrostomy tubes consisting of the complaint device and an additional 8.5fr ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-6s-clm-rh, lot# 14213941), reported under medwatch #1820334-2022-00122.The laterality of the devices is unknown.The 8.5fr catheter was placed three weeks before the 10.2fr catheter; however, the catheters were exchanged on the same day due to obstruction.Reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.The customer returned one device in a used condition.The mac-loc adaptor was not attached and/or returned.The flare at the proximal end of the catheter was not present.The point of separation appeared to be clean with no evidence of material elongation.Using a sample.038" wire guide, advancement of the wire guide to the distal tip was successful.No obstruction was noted; however, a ballooned area was noted at approximately 11cm from the distal end.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook completed a review of the dhr.The dhr for lot 13931337 and the catheter tubing sub-assembly lot (sa13791447) confirmed there was one relevant recorded nonconformance, under lot number 13931337 for "side ports rough", quantity of 3.These devices were scrapped prior to further processing.To date, a further search of our database records revealed this complaint to be the only reported complaint associated with the complaint lot number.Since there is objective evidence the dhr was fully executed, cook has concluded that there is no evidence that non-conforming product exists in house or in the field and that the device was manufactured to current specification.Cook 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: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ instructions for use: ¿under fluoroscopic control, perform standard techniques for placement of percutaneous draining catheters, either by seldinger access or trocar access.-once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to for its configuration.¿ 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, inspection of the returned device, and the results of the investigation, it was determined the cause of this event is related to component failure without any design or manufacturing deficiencies.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.

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 MULTIPURPOSE 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: 13361594
• MDR Text Key: 286351866
• Report Number: 1820334-2022-00123
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095021
• UDI-Public: (01)00827002095021(17)240430(10)13931337
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Device Lot Number: 13931337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 01/25/2022; 03/25/2022; 10/11/2022
• Supplement Dates FDA Received: 01/31/2022; 04/06/2022; 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male