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
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer (person: phone: (b)(6), postal code: (b)(6).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 that the shaft of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter separated from the hub.A photo of the device provided by the facility confirmed catheter/hub separation.Additional information regarding event and patient details has been requested, but is currently unavailable.
Additional Manufacturer Narrative
Additional information: b5, h6 - annex g.Correction: h6 - annex e, h6 - annex f.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 03dec2021, it was reported that the admitted patient did not experience any adverse effects due to this occurrence.The failure was noticed during the procedure, and a new device was used to complete the procedure successfully.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: as initially reported to customer relations: on (b)(6) 2021, cook india received a complaint from dr.(b)(6), a representative at the (b)(6) hospital , which reported the shaft of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult14.0-38-25-p-5s-cldm-hc; lot# 13638245) separated from the hub.Reviews of the complaint history, device history record (dhr), and instructions for use (ifu), were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include 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 dhr for the reported complaint device lot (13638245) and related sub-assembly lots revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was 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 ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.Based on the available information, no device return, and the results of the investigation, cook has concluded the root cause category would fall under cause traced to component failure, being defined as component failure without any design or manufacturing issue.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 or Problem Description
No additional information regarding the patient and/or event 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: 12736885
• Report Number: 1820334-2021-02428
• Device Sequence Number: 11902163
• Product Code: GBO
• UDI-Device Identifier: 00827002104365
• UDI-Public: (01)00827002104365(17)231217(10)13638245
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2022

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: 12/17/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT14.0-38-25-P-5S-CLDM-HC
• Device Lot Number: 13638245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 12/03/2021; 08/22/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/08/2021; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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