MAUDE Adverse Event Report: COOK INC FLEXOR INTRODUCER SHEATH

Catalog Number	KCFW-8.0-38-30-RB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report that was initiated during an fda inspection.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.(b)(4).Investigation - evaluation a review of the complaint history, manufacturing instructions, specifications, trends and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported the complaint device was returned in a used and damaged condition.The sheath had pulled from the cap with the flare intact; however, the flare was slightly elongated on one side.The flare was tested with the go, no go gauge and found to be within specification.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Based on the information provided, and the results of our investigation, it is feasible to suggest the device met resistance beyond its' design.However, a definitive root cause could not be determined.
Event or Problem Description
It was reported by the user facility that a patient underwent an evar procedure.The attending physician indicated before inserting into the patient body the hub separated from the sheath.The physician replaced flexor introducer sheath and was able to complete the procedure with no adverse effects or medical intervention due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Investigation - evaluation a review of the device failure analysis, device history record, risk documentation and a photographic inspection of the returned device was conducted as part of an additional investigation of the complaint device.The returned complaint device was destroyed following the initial completion of this investigation per procedures in place at that time.Photos of the returned complaint device were later examined as part of further investigation into the reported incident.The device was noted to be separated at the proximal fitting to the shaft connection.The dilator was inserted into the device.There were no signs of blood or biomaterial supporting the statement that the device malfunction occurred prior to patient contact.The flare was examined as part of the initial investigation and found to be properly sized and within specification.The original visual inspection and device measurements were found to be appropriate for the photographic evidence reviewed.No new issues were identified.Additionally, 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 all of the available information, examination of the returned device, and the results of the additional investigation the root cause remains undetermined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: FLEXOR INTRODUCER SHEATH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6291721
• Report Number: 1820334-2017-00236
• Device Sequence Number: 19259822
• Product Code: DYB
• UDI-Device Identifier: 00827002078789
• UDI-Public: (01)00827002078789(17)171211(10)5510190
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2017

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: KCFW-8.0-38-30-RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1