MAUDE Adverse Event Report: COOK INC FLEXOR INTRODUCER 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	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during an unspecified procedure while using a flexor introducer sheath, the sheath pulled apart from the check flo valve.It was also reported that the patient did not experience any adverse events due to this occurrence.No unintended section of the device remained inside the patient's body.
Additional Manufacturer Narrative
Investigation - evaluation: a review of dimensional verification, complaint history, device history record, documentation, manufacturing instructions, drawing, specifications, and quality control and visual inspection of the return device was conducted during the investigation.One used flexor balkin guiding sheath was returned with the sheath proximal fitting separated from the sheath tubing.The dilator was not returned.The proximal tubing was damaged and no flare was present.The proximal end was accordioned at 4.4 centimeters (cm).The check-flo was dissembled from the connector cap in order to determine if the flare was present.The separated flare of the sheath tubing was present between the connector cap and check-flo.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.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 information provided and results of the investigation, a definitive root cause could not be determined.Measures have been previously conducted to address this failure mode.Monitoring for similar complaints will continue.

• Brand Name: FLEXOR INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6564997
• Report Number: 1820334-2017-01001
• Device Sequence Number: 13669301
• Product Code: DYB
• UDI-Device Identifier: 00827002088672
• UDI-Public: (01)00827002088672(17)200314(10)7747936
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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-6.0-38-30-RB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1