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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) #: preamendment.(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 an ultrathane cope nephroureterostomy stent was selected for a drain exchange.One day after the exchange, the patient returned due to the hub separating from the catheter.The drain was replaced as a result of this event.No other adverse effects were reported for this incident.The exact date of event is unknown but the customer reported the event occurred within the past week or so from the manufacturer's aware date.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, as well as a functional test, visual inspection and dimensional verification of the returned device was conducted during the investigation.One locked 10.2fr mac-loc catheter was returned for evaluation in used and damaged condition.The device was returned in three pieces.The first piece consisted of the mac-loc hub, connector cap and a red stopcap.The second piece included approximately 2cm of catheter tubing starting with the flare and ending with a cut.The third piece was comprised of approximately 59cm of catheter tubing starting with a cut and ending with the distal pigtail curl.Biological matter was present on the device, and other than the cut, no additional surface damage was noted.Tug and twist tests revealed that the proximal assembly was secure.Upon removal of the connector cap, the suture string was found normal in the threads.The flare appeared lopsided and had a minor lip, but due to the compression of the flare within the cap and the potential for damage upon removal, it cannot be determined if the flare was manufactured to specifications.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.Inspection activities are in place to prevent the release of nonconforming product related to the reported failure mode.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include the manufacturing quality control checks and process validation.The technical files covering mac-loc catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record revealed no relevant nonconformances that could have contributed to this failure mode.It should be noted that there were no other complaints reported for lot 9144024 or similar device lots.The instructions for use (ifu) advise the user to inspect the product prior to use to ensure that no damage has occurred.Based on the information provided, examination of returned product and the results of our investigation, a definitive cause could not be established.Appropriate measures have been taken 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.
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: 8000658
• Report Number: 1820334-2018-03164
• Device Sequence Number: 201724
• Product Code: LJE
• UDI-Device Identifier: 00827002481664
• UDI-Public: (01)00827002481664(17)210906(10)9144024
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2018

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: 09/06/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-10.2-26-NUCL-B-RH
• Device Lot Number: 9144024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/31/2018
• 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
• Patient Age: 86 YR