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

Model Number N/A

Device Problem Gas/Air Leak (2946)

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

Event Date 08/08/2022

Event Type  Injury  

Manufacturer Narrative

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.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

It was reported that air leakage was noted at the hub of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter.In the process of drainage following a percutaneous transhepatic biliary drainage (ptbd) procedure, it was discovered that air was leaking from the hub, leading to no pressure within the catheter.The patient required an additional procedure to remove and replace the device.It was reported that the patient is "healthy." additional information regarding event details has been requested, but is currently unavailable.

Manufacturer Narrative

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

Additional information was received on 22sep2022.It was noted that there is doubt that the leak originated from the junction between the catheter mac-loc hub and catheter cap; however, it was difficult to determine where the leak occurred clearly.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation: it was reported by (b)(6) of (b)(6) hospital (republic of korea), that during drainage after a percutaneous transhepatic biliary drainage (ptbd) procedure, it was discovered that air was leaking from the hub of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult12.0-38-25-p-5s-cldm-hc; lot#: unknown).This led to no pressure within the catheter.The patient then required an additional procedure to remove and replace the device.It was reported that the patient is "healthy." further communication with the customer indicated that there is doubt the leak originated from the junction between the catheter mac-loc hub and catheter cap; however, it was difficult to determine where the leak occurred clearly.No other adverse effects were reported due to this occurrence.Reviews of the documentation, including the complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control procedures and specifications of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be completed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are currently in place to prevent the release of nonconforming product related to the reported failure mode.A review of the device history record (dhr) could not be completed due to the lack of lot information provided.Cook also reviewed product labeling.As the lot number is unknown, the most recent instructions for us (ifu) [t_multi2_rev1, ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter provided with the suspect rpn were reviewed for the information related to reported failure mode.Per the ifu, under the heading precautions, it states, ¿for best results, keep catheter surface wet during placement¿.The ifu also states under the heading how supplied, "upon removal from package, inspect the product to ensure no damage has occurred¿.Evidence gathered upon review of the dmr and ifu suggests that the device was not manufactured out of specification.There is no evidence suggesting nonconforming product exists either in house or in field.Based on the information provided, no returned product and the results of our investigation, it was concluded that a manufacturing and quality control deficiency contributed to the reported event.A capa was previously opened for this issue and corrective actions were implemented.As the lot number was not provided, it was unknown whether the complaint device underwent these corrections.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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 patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE DAWSON-MUELLER 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: 15279099
• MDR Text Key: 298437236
• Report Number: 1820334-2022-01385
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2023

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 Model Number: N/A
• Device Catalogue Number: ULT12.0-38-25-P-5S-CLDM-HC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 09/22/2022; 01/19/2023
• Supplement Dates FDA Received: 09/28/2022; 01/26/2023
• 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
• Patient Outcome(s): Required Intervention