MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX 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	04/20/2017
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 an unspecified procedure using a flexor high-flex ansel guiding sheath, the sheath and valve were separated during preparation for the procedure.There was no report of an adverse event related to the separation.
Additional Manufacturer Narrative
A review of the drawings, complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One used flexor high-flex ansel guiding sheath tubing and dilator were returned.The connector cap and the check-flo valve assembly were not returned.The distal end of the sheath is slightly compressed and one wrinkle is noted.The dilator was returned in sealed packaging.Flare on the sheath is damaged.It is unable to be determined whether the device was built to specification since the flare could have been damaged due to force and/or handling/shipping.There is no evidence to suggest the finished product was not made to specifications.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 information provided and the results of our investigation, a definitive root cause could not be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• 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: 6563198
• Report Number: 1820334-2017-00876
• Device Sequence Number: 616262
• Product Code: DYB
• UDI-Device Identifier: 00827002490451
• UDI-Public: (01)00827002490451(17)180824(10)NS6146521
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2017

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-8.0-35-55-RB-HFANL1-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1