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

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
Upon insertion into the female patient's radial artery for coronary diagnostics, the sheath flowered.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, instructions for use (ifu), manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.One used flexor radial access set sheath with an inserted dilator was returned for investigation.During visual inspection of the returned complaint device, it had been observed that a section of the sheath's distal tip had started to fold/buckle.The taper length of the sheath was measured to be approximately 0.18 in (4.6 mm).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.It should be noted 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, specific items are addressed such as: ¿upon removal from package, ensure the inner diameter (id) of the sheath is appropriate for the maximum diameter of the instrument or catheter to be introduced.Activate the hydrophilic coating by wetting the outer surface of the device with heparinized saline.Inspect the surface for any defects prior to use.Note: for best results, maintain wetted condition of device during placement.Do not attempt to insert of withdraw the wire guide and/or introducer if resistance is felt.¿ based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined; however, it is possible that the failure mode was caused by a high amount of force being applied to the device during the insertion process.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
Upon insertion into the female patient's radial artery for coronary diagnostics, the sheath flowered.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• 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: 5843383
• Report Number: 1820334-2016-00730
• Device Sequence Number: 446858
• Product Code: DYB
• UDI-Device Identifier: 00827002356030
• UDI-Public: (01)00827002356030(17)190401(10)6647605
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K132592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2016

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: KCFN-6.0-18-13-RA-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 12/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1