MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; LJE CATHETER, NEPHROSTOMY

Catalog Number	ULT8.5-8.5-22-NUCL-B-RH
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Occupation: unknown.Pma/510(k) #: pre-amendment.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 cope nephroureterectomy stent was placed in the patient for nephroureteral drainage on an unspecified date.Immediately upon placement, leakage was discovered at the hub.The drain was removed and replaced.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Requests have been made for additional information including patient information.However, none has been received.
Event or Problem Description
In additional information received on 16oct2018, it was noted that there were no issues or difficulties experienced during placement of the device.The date of the event was said to have happened "a few weeks ago".The exact date of event was not provided.
Additional Manufacturer Narrative
In additional information received on 16oct2018, it was noted that there were no issues or difficulties experienced during placement of the device.The date of the event was said to have happened "a few weeks ago".The exact fate of event was not provided.Reported to a regulatory agency: no.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Corrected data: a2-a4:asku.B7: asku.Additional information: d10: product received on: 22oct2018.Investigation evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, specifications, as well as a functional test, visual inspection and dimensional verification of the returned device was conducted during the investigation.Clinical assessment: in this case, a leaking hub could potentially cause inadequate drainage and possibly result in hydronephrosis.At this time, the most probable causes of this event are device handling, device failure or manufacturing related.One 8.5fr mac-loc catheter was returned for evaluation in damaged condition.The tubing had been cut approximately 1.8cm distal to the hub.The plastic cap was secure to the rest of the hub, and the tubing was secure within the cap.A leak test was conducted and confirmed the presence of a leak at the connection between the plastic cap and the tubing of the catheter.The thread count was measured and was found to be higher than specified.It is possible this contributed to the failure.Additionally, a document based investigation evaluation was performed.There are adequate controls in place to prevent the release of nonconforming product.A review of the device history record showed no relevant nonconformances that could have contributed to this failure mode.It should be noted that there were no other complaints reported for lot 9003162.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause could not be established.Appropriate measures have been taken to address this failure mode.The appropriate personnel have been notified and we 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 COPE NEPHROURETEROSTOMY SET
• Common Device Name: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7965010
• Report Number: 1820334-2018-03068
• Device Sequence Number: 11189148
• Product Code: LJE
• UDI-Device Identifier: 00827002481732
• UDI-Public: (01)00827002481732(17)210709(10)9003162
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 12/19/2018

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 Expiration Date: 07/09/2021
• Device Catalogue Number: ULT8.5-8.5-22-NUCL-B-RH
• Device Lot Number: 9003162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 10/16/2018; 12/13/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/06/2018; 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1