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

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem No Code Available (3191)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation: charge tech.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 Description

It was reported an ultrathane cope nephroureterostomy stent was used for a nephrostomy drain exchange in a patient.An unspecified amount of time after the procedure, leakage was discovered at the connection between the catheter and the hub.This leakage event is recorded under medwatch report #1820334-2018-03330.The drain was then replaced by an identical device from the same lot.The patient returned 9 days later due to persistent leaking again at the connection between the catheter and the hub.The drain was again replaced.This event is recorded under this medwatch report.No other adverse effects were reported for this incident.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Product received on: (b)(6) 2018 investigation - evaluation an inspection of unused product, a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, as well as a visual inspection and dimensional verification of the returned devices were conducted during the investigation.The defective device was not saved by the facility and was unable to be returned for evaluation.Five unused mac-loc devices from the same lot 9147537 were returned unopened in the original packaging for evaluation.No surface damage or biological matter was observed on any of the devices.Leak testing was performed, as well as tug and twist tests to determine the security of the proximal assembly.The connector caps were removed to observe the state of the suture string and catheter flares.Due to the compression of the flare within the cap and the potential for damage upon removal, it cannot be determined if the flares were manufactured to specifications.Device 1: the mac-loc was observed to be in the locked position.A leak was unable to be confirmed in the device and the proximal assembly was found to be secure.The suture was found to be normal in the threads, and the catheter flare appeared to be lopsided with a lip.Device 2: the mac-loc was observed to be in a locked position.A leak was unable to be confirmed in the device and the proximal assembly was found to be secure.The suture was found to be normal in the threads, and the catheter flare appeared to have a lip.Device 3: the mac-loc was observed to be in a locked position.A leak was unable to be confirmed in the device and the proximal assembly was found to be secure.The connector cap was unable to be removed from the hub.The suture string was adhered to the threads of the hub.Device 4: the mac-loc was observed to be in a locked position and a visual inspection found that the number of threads showing on the connector cap exceeded what was detailed in manufacturing specifications.A leak test was able to confirm the presence of a leak where the connector cap meets the catheter tubing, but the proximal assembly was secure.The suture string was found partially wound in the threads and the flare appeared lopsided.Device 5: the mac-loc was observed to be in a locked position.A leak test confirmed the presence of a leak where the connector cap meets the catheter tubing, but the proximal assembly was found to be secure.The suture string was found partially wound in the threads and the flare appeared to be lopsided.An additional complaint was opened for this failure mode.Additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the device history record revealed five nonconformance's for lot 9147537, in which one device was scrapped for poor print quality, eight devices were scrapped for a curve not per template, one device was reviewed and reversed for curve not per template, and one device was scrapped for incorrect/damaged end hole.Three nonconformance's were reported for the catheter tubing subassembly lot sa9038117, in which five devices were scrapped for being stuck together, one device was reworked for incorrect quantity and two devices were scrapped for foreign matter.One nonconformance was found in the mac-loc subassembly lot sa9038139 for falling on the floor.All devices were scrapped or reworked prior to release, and none of the reported nonconformance's were related to the failure mode.It should be noted that there was one other complaint reported for lot 9147537 that is related to the current device failure.The instructions for use (ifu) advise the user to inspect the device prior to use to ensure that no damage has occurred.Based on the information provided, examination of the 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.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
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8039138
• MDR Text Key: 126215246
• Report Number: 1820334-2018-03288
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)210907(10)9147537
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 9147537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPLATZ GUIDE WIRE
• Patient Outcome(s): Required Intervention