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

Model Number	G09706
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: buyer.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 or Problem Description
It was reported an unknown patient required placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for an unknown procedure.During the procedure, it was noted the catheter had an air leak.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional 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 or Problem Description
In additional information received on 22jul2021, it was reported that the leak was discovered during the initial placement procedure.The device was placed over a wire into an abscess cavity.A syringe was connected to the device and on first inspection, was found to be securely connected.No force was exerted on the catheter.Patient activity was reported to be free moving and not bed bound.A new device was opened to complete the procedure successfully.No additional interventions were required.
Additional Manufacturer Narrative
Investigation ¿ evaluation: on 22jun2021, cook medical inc.Received a complaint from a representative at the mayo clinic regarding an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter that developed an air leak originating from the cap and catheter connection during the procedure (rpn: ult10.2-38-25-p-5s-cldm-hc, lot: 13804394).Further information received on 22jul2021 stated that during placement, the device was placed over a wire into an abscess cavity.A syringe was connected to the device and found to be securely connected, with no force exerted on the catheter.The patient activity level was described as freely moving.A new device was used to complete the procedure with no additional intervention required.The patient did not experience any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), quality control procedures and specifications, as well as a visual inspection, functional test and dimensional verification of the returned device, were conducted during the investigation.One used device was received for evaluation.A leak test was performed and confirmed leakage at the cap and tubing connection.One thread was found to be showing between the mac-loc adapter and connector cap.The catheter was then removed from the mac-loc fitting and material folding/wrinkling within the bell of the flare was noted.It is currently unknown if this damage occurred during manufacturing or when removing the catheter tubing from the mac-loc adapter.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.The risk specifications covering mac-loc drainage catheters includes hub separation as a potential failure mode.The identified risk controls include the manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record (dhr) for lot 13804394 found no related nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.The ifu, t_multi_rev5, supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.Evidence provided by the dmr, dhr, and device failure analysis show no indication the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.There is no evidence of design or manufacturing deficiency.Based on the information provided, examination of the returned product and the results of our investigation, a likely cause for the event is a component failure.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 or Problem 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
• Common Device Name: 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: 12102874
• Report Number: 1820334-2021-01661
• Device Sequence Number: 17085860
• Product Code: GBO
• UDI-Device Identifier: 00827002097063
• UDI-Public: (01)00827002097063(17)240305(10)13804394
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2024
• Device Model Number: G09706
• Device Catalogue Number: ULT10.2-38-25-P-5S-CLDM-HC
• Device Lot Number: 13804394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/22/2021; 07/11/2022
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/23/2021; 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown