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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: unknown.Pma/510(k) #: exempt.(b)(4).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 a patient required three ultrathane mac-loc locking loop multipurpose drainage catheter replacements due to leaking.The replacements are described below: the patient had 10 fr bilateral nephrostomy tubes implanted on (b)(6) 2019.On (b)(6) 2019, the patient returned due to leaking on the right side.The nephrostomy tubes on both sides were exchanged for cook 12 fr catheters on (b)(6) 2019 to keep the exchange schedule the same for both sides.This event is recorded under patient identifier (b)(6).On (b)(6) 2019, the patient returned due to leakage from the drain on the right side.Both drains were exchanged again for drains of the same type and size.This event is recorded under patient identifier (b)(6).On (b)(6) 2019, after the catheter exchange, the left drain was found leaking from the hub at the connection with the drainage bag.The drainage bag was replaced but the leaking continued.The 12 fr drain was then exchanged again without further incident.The drain was found to be cracked at the hub distal end.This event is recorded under patient identifier (b)(6).No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.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 were conducted during the investigation.No device was returned for investigation.A previous complaint (captured under medwatch report #1820334-2019-01101) was received for a similar device with the same failure mode, and the returned device was confirmed to have a leak, but the device was confirmed to be manufactured within cook¿s specification.The investigation in this prior complaint could not establish a definitive root cause for the failure.Additionally, 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.Cook also completed a review of the device history record (dhr) for this incident.One relevant nonconformance was recorded on the reported lot.One additional complaint on the reported lot was found in the field, but this is from the same hospital for the same patient.Due to no additional lots exhibiting applicable nonconformances, no additional complaints from other customers, and a 100% inspection for the nonconformance, there is no evidence suggesting that nonconforming product from these lots exists in house or in the field.Based on the information provided, no returned product and the results of the investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.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.
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 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: 8830815
• Report Number: 1820334-2019-01810
• Device Sequence Number: 2838780
• Product Code: GBO
• UDI-Device Identifier: 00827002095038
• UDI-Public: (01)00827002095038(17)220517(10)9748686
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-25-P-6S-CLM-RH
• Device Lot Number: 9748686
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 73