MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; FAD STENT, URETERAL

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: ir lab manager.Pma/510(k) #: k171603.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 unknown patient required an ultrathane cope nephroureterostomy set for a nephroureteral drain placement through stricture.During deployment, the user noted the catheter sticking on the stiffening cannulas of two devices.The first device accordioned and would not separate from the catheter.The second device broke in half, but didn't separate fully into the patient.A third device was tested prior to use and the same failure was noted.A larger drain was utilized to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The two devices that made patient contact are reported on the medwatch report with patient identifier (b)(6) (this report).The device tested prior to patient contact is reported on the medwatch report with patient identifier (b)(6).
Additional Manufacturer Narrative
D10 ¿ product received on: 27aug2020.Investigation ¿ evaluation: piedmont fayette hospital in the united states informed cook of an incident involving three ultrathane cope nephroureterostomy sets that were from the same procedure performed on 19aug2020.All devices were for difficult removal of the blue flexible stiffener.Two were used in the patient and are captured in this report.One device was prior to patient contact and will be reported under medwatch report #1820334-2020-01582.For one of the used devices, the flexible stiffener was accordioned and could not be removed.For the second used device, the stiffener broke in half.No section remained inside the patient.All surfaces of the devices were wetted and a larger cook nephroureterostomy device (10 fr) was used to complete the procedure.No unintended section of the device remained inside the patient¿s body, the patient did not require additional procedures due to this occurrence and there have been no adverse effects to the patient due to this occurrence.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.The complainant returned two devices to cook for investigation.Two 8.5 fr catheters were returned with biomatter present.Two blue flexible stiffeners were returned separated into two sections.Each had one section inside the catheter and the other outside of the catheter.One section was lodged on a wire guide and could not be removed due to elongation of the flexible stiffener.One stiffener's separated section measured to be 41.5cm in length and the second stiffener's separated section measured to be 35.8cm in length.The proximal fittings for both stiffeners were not returned.The inner diameter of the catheters and the outer diameter of the flexible stiffeners were measured to be within specification.Could not perform a function test to see if the stiffener can be removed from the catheter because the stiffeners were returned separated.Additionally, a document-based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of product labeling and instructions for use (ifu) packaged with the device was reviewed for the related reported failure mode.The following information was provided: precautions: "activate hydrophilic coating, if present, by wetting surface of device with sterile water or saline.For best results, maintain wetted condition of device during placement." instructions for use: stent placement "1.Using standard percutaneous access technique, establish wire guide position well into the bladder.5.Over the wire guide, introduce the stent/stiffening cannula into the kidney collecting system.6.After establishing proper proximal and distal position, push the stent off the stiffening cannula over the wire, making sure the distal pigtail forms within the bladder.7.Remove the stiffening cannula from the stent, leaving the wire guide in place.¿ the device history record (dhr) was reviewed for the final lot, sub assembly lot, and raw material lot.Cook concluded that the recorded non-conformances for the lots are not related to this incident.Additionally, a complaint database search was performed.No additional complaints were found.As there are adequate inspection activities established, objective evidence that the dhr was fully executed, no related non-conformances and no additional complaints from the same lot, it was concluded that there is no evidence that nonconforming product exists in house or in field.Even though the customer said only one flexible stiffener separated, both were returned separated.This most likely occurred if force was used to pull the stiffener during the difficult removal.Based on the information provided, examination of the returned products, and the results of the investigation, a definitive root cause could not be established.A capa has been opened to address this issue and is currently undergoing investigation.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10465765
• Report Number: 1820334-2020-01581
• Device Sequence Number: 19430884
• Product Code: FAD
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)221206(10)10196887
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/08/2020

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: 12/06/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 10196887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK LUNDERQUIST WIRES; TERUMO GLIDEWIRE ADVANTAGE; TERUMO STIFF GLIDEWIRE; UNKNOWN MANUFACTURER AMPLATZ WIRE; COOK LUNDERQUIST WIRES; TERUMO GLIDEWIRE ADVANTAGE; TERUMO STIFF GLIDEWIRE; UNKNOWN MANUFACTURER AMPLATZ WIRE