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	10/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported the physician was performing a peripheral case via groin access and during the exchange the sheath separated from hub.The sheath was successfully retrieved with hemostats.A section of the device did not remain inside the patients body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Evaluation- a review of the complaint history, device history record, device history record, drawings, instructions for use (ifu) manufacturing instructions (mi), quality control (qc) and device specifications was performed during the course of investigation.The complaint device nor photo image of the failure were not provided to assist with the investigation.The ifu states, "precautions: when inserting, manipulating, or withdrawing a device through an introducer always maintain introducer position.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Sheath removal: insert wire guide at least 10cm past the tip of the sheath.Insert the dilator over the wire into the sheath.Withdraw the sheath and dilator as a unit.Remove the wire guide." a complaint history search revealed this complaint to be the only reported complaint associated to the complaint lot number.There is no evidence to suggest the product was not manufactured to specification.Because the complaint device was not returned for investigation, we could not verify the dimension of the connector cap, nor could we verify if the flare size was manufactured to specification.If product is returned, the complaint will be updated.It is possible that the reported failure could be attributed to the patients pre-existing condition (scarred groin and may have had a tortuous or calcified anatomy), the medical procedure/technique, or to the manufacturing of the device.Without the benefit of a returned complaint device, and with the information known, a definitive root cause cannot be determined.We will continue to monitor for similar events.

• 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: 6106581
• Report Number: 1820334-2016-01343
• Device Sequence Number: 890085
• Product Code: DYB
• UDI-Device Identifier: 00827002299863
• UDI-Public: (01)00827002299863(17)190805(10)7175253
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention