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	05/04/2017
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, using a flexor ansel guiding sheath, the check-flow valve and catheter were separated.The patient outcome was not provided.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, manufacturing instructions, specifications, and quality control was conducted during the investigation.One used flexor ansel guiding sheath was returned for evaluation.The dilator was not returned.The sheath was returned with the tubing separated from the hub.The flare passed through the larger setting but did not pass through the smaller setting.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 available information and results of the investigation the most likely root cause could not conclusively be determined.Measures have been previously conducted 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: 6605271
• Report Number: 1820334-2017-01065
• Device Sequence Number: 11015412
• Product Code: DYB
• UDI-Device Identifier: 00827002299863
• UDI-Public: (01)00827002299863(17)190728(10)7154821
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• 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-7.0-18/38-45-RB-ANL2-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1