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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2017
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 lower extremity angiogram procedure, using a flexor ansel guiding sheath, while attempting to retract the sheath the hemostatic valve came apart from the sheath and the sheath began to uncoil.It was reported that the end user was able to remove the device and finish the procedure.There was no unintended section of the device that remained inside the patient's body.There no adverse effects on the patient reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of complaint history, device history record, documentation, manufacturing instructions, drawing, dimensional verification, and quality control data was conducted during the investigation.One used the flexor ansel guiding sheath was returned was returned for evaluation.The check-flo valve assembly was returned separated from the sheath tubing.Exposed coil was exiting the proximal end of the sheath tubing.The connector cap was disassembled from the check-flo body and no flare was present.Fraying was present at the proximal end of the sheath tubing.The distal tip of the sheath tubing was compressed.Measurements were unable to taken due to damage of the flare.A document based investigation evaluation was also performed.Review of device history record shows no nonconforming events which could contribute to this failure mode.There were no other reported complaints for this lot number.Based on the provided information and results of the investigation a definitive root cause could not be determined.Measures have been initiated to address this failure mode.Monitoring for similar complaints will continue.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6565022
• Report Number: 1820334-2017-01005
• Device Sequence Number: 628027
• Product Code: DYB
• UDI-Device Identifier: 00827002299832
• UDI-Public: (01)00827002299832(17)180623(10)5977848
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/21/2017

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-6.0-18/38-45-RB-ANL2-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1