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

Model Number N/A

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: cook neff percutaneous access set.Occupation: unknown.Pma/510(k) #: preamendment.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 set was used in a (b)(6) year old male patient for a nephroureterectomy.As reported, after the stent was inserted, "it was not possible to remove the flexible catheter, this remained stuck to the stent.When the nephroureterostomy stent was removed from the patient's body, the flexible catheter was adhered to the nephroureterostomy stent." it was further reported that a part of the flexible catheter (stiffener) was inside the patient's body, but became stuck inside the stent when the stent was removed.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.B5 - event description: additional information was provided by the customer on (b)(6) 2019.There were malfunctions on two devices with the same product information during this event.The first device was placed and the flexible cannula was unable to be removed.The nephroureterostomy stent with the flexible stiffener inside was removed from the patient as a result.The second device was placed and the flexible cannula separated upon removal.The stent was immediately removed and the separated piece was found inside the removed stent.A replacement ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was placed instead.It was also reported the devices were placed via seldinger technique while the patient was under sedation.No adverse effects were reported for this incident.Correction: the initial date aware for this information was (b)(6) 2019, not (b)(6) 2019.The initial report was submitted on (b)(6) 2019.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

See h10.

Manufacturer Narrative

Investigation/evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, cook received a complaint for the same product experiencing the same failure mode under a different complaint.Physical examination of the complaint device returned in this complaint showed that the stiffener could not be completely inserted through the stent.The stiffener contained kinks, and the tubing was accordioned and elongated just below the hub.The components were measured to be within the correct specifications and tolerances.The investigation under the other complaint concluded that a definitive conclusion could not be made, but the event was likely related to unknown issues during the procedure.Because of the similarities between the two cases, it is likely that the two events have a similar cause.With the known information on the complaint device, there is no evidence to suggest the device was not manufactured within the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.The device history record for the lot of the complaint device revealed no relevant nonconformances.The catheter subassembly lot revealed two nonconformances, but neither were related to the reported failure mode.A software search revealed no other complaints have been reported from the complaint device lot.As there are no related nonconformances or complaints received from the field from the same lot, there is no evidence to suggest there is nonconforming product in house or out in the field.Cook also completed a review of the product device master record and has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided, no inspection of returned product and the results of the investigation, a definitive cause could not be established.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 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
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8726388
• MDR Text Key: 148976904
• Report Number: 1820334-2019-01501
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481732
• UDI-Public: (01)00827002481732(17)211231(10)9413304
• 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
• Report Date: 07/16/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-22-NUCL-B-RH
• Device Lot Number: 9413304
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 06/21/2019; 07/15/2019
• Supplement Dates FDA Received: 06/24/2019; 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 52