MAUDE Adverse Event Report: COOK INC FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS; KOE DILATOR, URETHRAL

Catalog Number	FUS-120045-P
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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, during a ureteroscopy with laser lithotripsy, the sheath of the flexor parallel ureteral access sheath and dilator advanced too far and engulfed the stone.A piece of the inner lining of the sheath came out.They were able to remove the stone when removing the sheath.The procedure was completed successfully.No section of the device remained inside the patients body.No adverse events have been reported as a result of the alleged malfunction.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.(b)(6).Investigation ¿ evaluation the complaint device was not returned for an evaluation.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, and specifications.A photo was supplied by the reporting facility.A length of clear material and a kidney stone are shown in the image.The device history record was reviewed noted there are no conformances that may have caused or contributed to this incident.A review of complaint history records revealed this is the only complaint associated with the complaint device lot number 9017358.A review of the design history did not identify any anomalies.A review of manufacturing and quality documents identified the device is inspected before shipment.A product was not returned, a picture was provided showing the lining of the sheath has separated.Based on the provided information, the cause of the complaint was not able to be established.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.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 or Problem Description
There has been no new information received since the last report was submitted.

• Brand Name: FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS
• Common Device Name: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7819001
• Report Number: 1820334-2018-02615
• Device Sequence Number: 16731224
• Product Code: KOE
• UDI-Device Identifier: 00827002564367
• UDI-Public: (01)00827002564367(17)210713(10)9017358
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K961904
• 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): 10/11/2018

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: 07/13/2021
• Device Catalogue Number: FUS-120045-P
• Device Lot Number: 9017358
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1