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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: unknown.Pma/510(k) #: pre-amendment.(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 the physician placed an ultrathane cope nephroureterectomy stent for urinary drainage.Per the customer, "the tube leaked immediately when it was inserted.Patient waited in the recovery room and was brought back in and had the tube replaced".It was also reported the device was in place for 10 minutes.Additional information clarifying outcome/type of event has been requested but is currently unavailable.
Additional Manufacturer Narrative
Concomitant medical product received on: 30oct2018.Investigation - evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, as well as a functional test, visual inspection and dimensional verification of the returned device was conducted during the investigation.One unlocked 8.5fr mac-loc catheter was returned for evaluation.The returned device was comprised of the mac-loc hub, connector cap and a blue adapter.No tubing was returned with the device.Biological matter was present on the device, indicating that it was likely used.A twist test conducted revealed that the proximal assembly was secure.Upon removal of the connector cap, the suture string was found wound in the threads.Since the catheter tubing was not returned, measurements could not be performed.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances, however, a visual inspection noted that the number of threads showing on the cap exceeded what was detailed in manufacturing specifications.Additionally, a document based investigation evaluation was performed.Based on the current documentation, inspection activities are in place to prevent the release of nonconforming product related to the reported failure mode.A review of the device history record revealed no relevant nonconformances in lot 8971919 that could have contributed to this failure mode.One nonconformance was revealed for the mac-loc hub subassembly lot for the mac-loc being out of place in which all the affected devices were scrapped.It should be noted that there was one other complaint reported for this lot number, in which the same failure from the same hospital was reported on a different date.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause could not be established.The device was out of specification, as the number of threads on the cap exceeded what was detailed in the specifications.It is likely that this device nonconformance can be attributed to manufacturing although this could not be confirmed.Appropriate measures have been taken to address this failure mode.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.
Event or Problem Description
No new event description information to report at this time.

• 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: 7991779
• Report Number: 1820334-2018-02542
• Device Sequence Number: 1572169
• Product Code: LJE
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)210622(10)8971919
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 06/22/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 8971919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/11/2018
• 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