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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported upon completion of an intervention of a contralateral superficial femoral artery (sfa) the physician was pulling the sheath out when the hub of the sheath separated from the sheath.The bifurcation was reported to be normal however the physician noted the access site was extremely scarred.No additional information was provided regarding patient outcome.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation : a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported one (1) used/damaged sheath was returned with the hub separated.Four (4) hemostat marks were observed on the sheath tubing: 1, 2.5, 14.3, and 25.5 cm from the hub.There were no signs of significant damage to the flare.A go no-go flare gauge was used to verify that the flare size was manufactured to specification.The connector cap was found to accept a 0.139 in pin gauge.A document based investigation evaluation was 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.Based on the information provided, examination of the returned device and the results of our investigation, it is feasible to suggest that the hub had separated from the sheath due to the device being manufactured with an inappropriate sized connector cap.We will continue to monitor for similar complaints.Per the health risk assessment no further action is required.
Event or Problem Description
It was reported upon completion of an intervention of a contralateral superficial femoral artery (sfa) the physician was pulling the sheath out when the hub of the sheath separated from the sheath.The bifurcation was reported to be normal however the physician noted the access site was extremely scarred.No additional information was provided regarding patient outcome.

• 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: 5821994
• Report Number: 1820334-2016-00772
• Device Sequence Number: 19013260
• Product Code: DYB
• UDI-Device Identifier: 00827002299863
• UDI-Public: (01)00827002299863(17)190315(10)6812086
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2016

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: KCFW-7.0-18/38-45-RB-ANL2-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 11/23/2016
• Patient Sequence Number: 1