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)
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 using a flexor high-flex ansel guiding sheath, the hub of the dilator fell off with minimal manipulation during the prepping process for the device.This occurred away from the patient.Another flexor high-flex ansel guiding sheath was opened and used to complete the procedure.The patient did not experience an adverse effects due to this occurrence.
Additional Manufacturer Narrative
Corrected data: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.A flexor high-flex ansel guiding sheath and dilator were returned for investigation.Biomatter was present on the outside and inside of the sheath tubing, on the sheath's proximal fitting, and within the connecting tube assembly.A significant amount of biomatter was present on the dilator tubing as well.Also, green discoloration was observed on the distal portion of the dilator.The dilator was returned with the proximal fitting separated from the tubing.The sheath's distal tip was found to be severely wrinkled.The inner diameter of the connector cap of the dilator and the flare measured within specification.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: 6541768
• Report Number: 1820334-2017-00892
• Device Sequence Number: 10766893
• Product Code: DYB
• UDI-Device Identifier: 00827002562790
• UDI-Public: (01)00827002562790(17)190520(10)6985437
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

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-12.0-35-45-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1