MAUDE Adverse Event Report: COOK INC FLEXOR RADIAL ACCESS SET; DYB INTRODUCER, CATHETER

Catalog Number	KCFN-5.0-18-13-RA-HC
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During an unknown procedure involving a flexor radial access set, it was reported that the valve did not worked correctly and lack of blood was noted.According to the initial reporter, the patient did not experience any adverse effect due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Evaluation narrative: a review of the complaint history, device history record, instructions for use (ifu), and quality control was conducted during the investigation.The complaint device was not returned, therefore no physical examination could be performed.However, a document-based investigation was performed.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.The device is shipped with an instruction for use (ifu) that describes the intended use.Per the ifu: "all instruments or catheters used with this product should move freely through the valve and sheath.Damage to the valve/introducer may result when the fit is tight.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Monitoring will continue to be performed for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: FLEXOR RADIAL ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5918198
• Report Number: 1820334-2016-00895
• Device Sequence Number: 587688
• Product Code: DYB
• UDI-Device Identifier: 00827002356009
• UDI-Public: (01)00827002356009(17)180910(10)6117310
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K132592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• 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 Catalogue Number: KCFN-5.0-18-13-RA-HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2016
• 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