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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device available for evaluation: unknown.(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 an unknown patient required placement of an ultrathane mac-loc locking loop multipurpose drainage catheter for a nephrostomy tube change procedure.After placement, the operator noted "the blue dilator getting stuck, hard to get through and difficult to get back out." upon "retrieval" of the dilators, the suture string "snapped".This failure occurred one more time with another device of the same lot.The device was replaced with a similar device to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Product received on: 20nov2019 investigation ¿ evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.Two ult catheters with flexible stiffeners for investigation.Physical examination of the returned device showed biomatter present on both catheters and stiffeners and that both catheters were cut.One flexible stiffener was returned without a hub.Both flexible stiffeners were returned with kinks and bends within them.The flexible stiffener with fitting had a kink located at 6 mm from the hub and showed elongation starting at 5 mm from the hub and was 1 cm in length.The flexible stiffener without the hub showed elongation starting at the proximal end and was 17.2 cm in length.Dimensions deemed relevant to the reported failure mode were analyzed and determined that the devices were manufactured within specification.Additionally, a document based investigation evaluation was performed.Risk specification states that adequate risk mitigation activities are in place to capture potential failure modes prior to customer release and the risks associated with these devices are acceptable when weighed against the benefits the device is shipped with instruction for use (ifu) which notes: precautions: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ a review of the device history record for the reported lot and related subassembly lots was also conducted and found no relevant nonconformances.A database search for complaints on the reported lot found no additional complaints reported from the field.At this time, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.It¿s possible that the catheter wasn¿t flushed prior to inserting the flexible stiffener, or that the suture wasn¿t pulled taught, but this cannot be confirmed.Based on the information provided, the examination of returned product and the results of the investigation, it was concluded that a component failure without a manufacturing or design defect contributed to this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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 MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9329880
• Report Number: 1820334-2019-02899
• Device Sequence Number: 19479955
• Product Code: GBO
• UDI-Device Identifier: 00827002097667
• UDI-Public: (01)00827002097667(17)220815(10)9951255
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-45-P-6S-CLM-RH
• Device Lot Number: 9951255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1