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

Catalog Number	FUS-120045
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: semi-rigid and flexible scopes, motion hybrid wire guide.(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 the physician was using the flexor ureteral access sheath with the scope, and the inner ¿liner¿ from the outside sheath peeled away.Case was completed as normal.Additional information was provided during follow up.The sheath was taken out of the patient and the stent was placed.No unintended section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.There were no adverse effects to the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, and quality control data.One opened package labeled rpn fus-140045 with label lot number 8010615 was received.Only the sheath was returned.The dilator was not returned.A visual examination of the distal tip revealed the edge had a ragged appearance.Under magnification scrape marks were observed on the sidewall near the tip.A section of the inner lining has been scraped off exposing some of the coils; this section of lining was not returned.The remaining lining has pulled away from the sheath's sidewall.Sheath was likely damaged when introducing instrument(s) and scraping the sidewall during transition.A review of the device history record noted there were no non-conformances related to the reported failure.A search of complaint records revealed this is the only complaint associated with complaint lot number 8010615.The document review and device history records did not identify any manufacturing or process anomalies with the device.The returned device confirmed the customer¿s complaint.Based on the returned device showing indications of being scraped it is possible that procedural and clinical factors have impacted this event as reported.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
No new information has been received since the last report was submitted on 07aug2018.

• Brand Name: FLEXOR 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: 7757486
• Report Number: 1820334-2018-02437
• Device Sequence Number: 1280277
• Product Code: KOE
• UDI-Device Identifier: 00827002461680
• UDI-Public: (01)00827002461680(17)200622(10)8010615
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K961904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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: 06/22/2020
• Device Catalogue Number: FUS-120045
• Device Lot Number: 8010615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1