MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that during a peripheral intervention procedure using a flexor high-flex ansel guiding sheath, at the end of the case, the valve started to leak.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use, manufacturing instructions, quality control data, and visual inspection/functional testing of the returned device were conducted during the investigation.The sheath of the flexor high-flex ansel guiding sheath was returned with the dilator fully inserted.No damage was visible.The dilator was removed from the sheath and tested for leakage.Leakage was detected from the check-flo disc.The silicone disc was visually examined within the check-flo assembly and no tears or damage were visible.The check-flo assembly was disassembled to examine the disc.The silicone disc was positioned correctly within the check-flo.A small tear was noted in the center of the disc on the inferior side.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the examination of the returned complaint device and the available information, the likely cause of the failure is attributed to the healthcare professional¿s technique/procedure.Many devices were being inserted and withdrawn from the sheath which could have caused a tear in the silicone disc, which might have led to leakage.Per the quality engineering risk assessment, no further action is warranted.We will notify the appropriate personnel and continue to monitor for similar complaints.
Event or Problem Description
It was reported that during a peripheral intervention procedure using a flexor high-flex ansel guiding sheath at the femoral artery, the valve started to leak at the end of the case.Access was gained contralaterally.The patient did not experience any adverse effects due to this occurrence.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6602375
• Report Number: 1820334-2017-00985
• Device Sequence Number: 369334
• Product Code: DYB
• UDI-Device Identifier: 00827002562219
• UDI-Public: (01)00827002562219(17)200208(10)7658739
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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): 08/08/2017

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 Model Number: N/A
• Device Catalogue Number: KCFW-6.0-35-70-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1