MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Catalog Number	ULT8.5-8.5-24-NUCL-B-RH
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 during a routine nephroureteral tube change, the new ultrathane cope nephroureterectomy set leaked less than five minutes after insertion.The device was removed and another like device was used to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation and a visual inspection/dimensional verification/functional test of the returned device were conducted during the investigation.Clinical assessment: a leaking hub could cause inadequate drainage or possibly infection potentially causing significant harm.At this time, the most probable causes of this event are user technique or manufacturing related.The visual inspection of the returned device confirmed that the number of threads showing between the mac-loc hub and connector cap was out of specification.The leak test was unable to confirm the presence of a leak.The clinical assessment stated that a leaking hub could cause inadequate drainage or possibly infection potentially causing significant harm.At this time, the most probable causes of this event are user technique or manufacturing related.Additionally, a document based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, the actual root cause was determined as manufacturer related.This failure mode has been escalated per internal processes.Additionally, the applicable department is currently going through defect awareness training for all personnel, therefore additional retraining will not be requested.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
No new event description information to report at this time.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7525040
• Report Number: 1820334-2018-01458
• Device Sequence Number: 1626740
• Product Code: GBO
• UDI-Device Identifier: 00827002481763
• UDI-Public: (01)00827002481763(17)210205(10)8562567
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/11/2018

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 Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1