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)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date unknown, sometime last week (at the time of (b)(6) 2018).It is uncertain that both devices will be returned, at least one has been confirmed for return.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 ultrathane mac-loc locking loop multipurpose drainage catheter was placed in the patient for an unspecified drainage procedure.The physician attempted to remove the stiffening cannula and experienced resistance.After several removal attempts the cannula broke.The physician was successful in removing all parts of the complaint device and the procedure was attempted with a replacement device.The replacement cannula was also difficult to remove and broke.All parts of the replacement device were removed and the procedure was completed with a third catheter of the same type.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.Investigation evaluation: a review of the complaint history, device history record, quality control, and specifications of the device, as well as a visual inspection, dimensional verification, and supplier investigation, were conducted during the complaint investigation.The returned catheter was fractured and separated around 10cm from the hub.The stiffener was also separated into two pieces, each piece lodged in each segment of the catheter.The distal segments were unable to be separated.There were also numerous areas of elongation on the catheter.Additionally, a document based investigation evaluation was performed.Sufficient controls are in place to detect this failure mode prior to release.A review of the device history record showed one related nonconformance in which the device was scrapped.It should be noted there was one other reported complaint for this lot number.The affected components are supplied to cook by an external supplier.A supplier investigation was requested.No non-conformances related to the failure mode were found.The supplier concluded the main contributing cause of failure does not appear to be manufacturing related.Based on the information provided, the examination of the returned product, and the results of the investigation, a definitive root cause could not be determined.Appropriate measures are being conducted to address this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook 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.

• 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: 8160634
• Report Number: 1820334-2018-03509
• Device Sequence Number: 13909752
• Product Code: GBO
• UDI-Device Identifier: 00827002289161
• UDI-Public: (01)00827002289161(17)210815(10)9095634
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 03/04/2019

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: 08/15/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-60-P-6S-CLM-RH
• Device Lot Number: 9095634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1