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

Catalog Number	FUS-107035-P
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: last week of (b)(6) or first week in (b)(6) exact date unknown.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 procedure, stringy material was entering the bladder when the inner dilator of sheath was going through lumen of sheath and protruding from end of sheath of the flexor parallel ureteral access sheath and dilators.A new access sheath was used to complete the procedure.It was reported the stringy material from inside the lumen of the sheath was coming off and being left in the bladder.No adverse events have been reported as a result of the alleged malfunction.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, and quality control data.One opened package labeled rpn fus-107035-p and label lot number 8771956 was received.The flexor was returned partially extending from the proximal end of the sheath.During examination, the dilator was pushed fully into the sheath locking the hubs together.When exiting the distal end of the sheath the dilator pushed out a strip of the sheath's inner lining.The inner lining was stuck to the dilator by aq coating.The inside of the sheath has been scraped by an instrument of undetermined origin causing delamination of the inner lining.A review of the device history record noted there was one non-conformance that is potentially related to the complaint as it is for poor transition between the dilator and sheath.However, a review of the non-conformance report showed there is no indication that the non-conformance resulted in the separation of material from the inner lumen.A search of complaint records found this is the only complaint associated with lot 8771956.This product is inspected in manufacturing for the transition between the dilator and the sheath as well as visually inspected.During examination of the returned complaint device, the dilator was pushed fully into the sheath locking the hubs together.When exiting the distal end of the sheath the dilator pushed out a strip of the sheath's inner lining.The sheath inner lining appeared to have been scraped by another device.It is possible that the sheaths lining was damaged during the procedure by another device.Cause traced to user; unintended use error caused or contributed to event.Per the quality engineering risk assessment, no further action is required.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 submission of the last report on 24jul2018.

• 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: 7714045
• Report Number: 1820334-2018-02142
• Device Sequence Number: 13678871
• Product Code: KOE
• UDI-Device Identifier: 00827002348738
• UDI-Public: (01)00827002348738(17)210413(10)8771956
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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: 04/13/2021
• Device Catalogue Number: FUS-107035-P
• Device Lot Number: 8771956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/17/2018
• 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: URETEROSCOPE; URETEROSCOPE