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

Model Number N/A

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problems Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

Occupation: "ir".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 Description

It was reported a male patient required placement of an ultrathane cope nephroureterostomy set in the bladder ureter to the kidney.Once the catheter was advanced to the bladder, the stiffener was difficult to remove.While attempting to remove the stiffener, the "end cap broke off".A second device was used and experienced the same failure.The patient was reportedly "unstable" and experienced nausea, bleeding and pain during the procedure.No other adverse effects were reported.The first device is captured under patient identifier (b)(6).The second device is captured under patient identifier (b)(6).

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: d10, h3 this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information provided 28jan2021 stated that products from other vendors were required which affected the length of the procedure and the recovery of the patient.The patient became unstable and the patient's condition did not allow for the procedure to be completed.The patient returned at a later time to complete the procedure.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation health sciences north in canada reported an incident involving a ultrathane cope nephroureterostomy set.On (b)(6) 2020 during a procedure the stiffener was difficult to remove.When trying to remove the stiffener, the end cap broke off.The device was inserted over an amplatz wire and everything was flushed.No unintended section of the device remained inside the patient¿s body.The patient had adverse effects of nausea, bleeding and pain.Because of the adverse effects, the patient had to return for an additional procedure to complete the initial procedure.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.One used 8.5fr catheter was received.Visual inspection found the blue flexible stiffener lodged in the catheter and the fitting separated.The proximal end of the stiffener is elongated.The stiffener was able to be removed with some force and there was biomatter on the stiffener.There was no visible damage to the catheter.The catheter was cut to obtain measurements.The catheter¿s inner diameter and flexible stiffeners outer diameter were measured within specification.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.The device history record (dhr) was reviewed.The dhr for the complaint lot records non-conformances.The catheter sub-assembly lots and the stiffener raw material lot records one non-conformance.Cook concluded that the recorded non-conformances are not related to this incident.A database search was completed on the complaint lot and 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.Cook also reviewed product labeling.The product ifu provides the following information to the user related to the reported failure mode: 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.¿ how supplied "upon removal from package, inspect the product to ensure no damage has occurred." a capa was previously opened to address this issue.The complaint lot was manufactured prior to implementation activities of the capa.The capa concluded that the inner diameter of the catheter was undersized due to lack of in-process inspection dimensions and material shrinkage.Based on the information provided, inspection of returned product, and the results of investigation, the conclusion falls under the capa and the investigation conclusion will conclude with a manufacturing deficiency and quality control deficiency.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: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10824974
• MDR Text Key: 223763893
• Report Number: 1820334-2020-02072
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)221002(10)10056903
• 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,Followup,Followup
• Report Date: 04/05/2021

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: 10/02/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 10056903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/11/2020; 01/28/2021; 03/11/2021
• Supplement Dates FDA Received: 11/20/2020; 02/03/2021; 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC 180CM 0.035 AMPLATZ WIRE; BOSTON SCIENTIFIC PERCUFLEX; COOK 5FR 65 CZ GLIDE CATHETER; COOK BILIARY DRAIN; MERIT STIFF LAUREATE WIRE; SOF-FLEX AQ PIGTAIL URETERAL CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 170