MAUDE Adverse Event Report: COOK INC FLEXOR SHUTTLE SELECT 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
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 instructions for use (ifu), manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use as upon removal from package; inspect the product to ensure no damage has occurred.The visual inspection of the returned device reported that where some elongation of the coil and ductile separation of the sheath material near the hub of the check-flo valve.After further investigating the device, it can be seen that the coils of the sheath extended into the connecting cap.It was also noted that there was blood in the hub of the sheath and on the tip of the sheath.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, a definitive root cause could not be determined.
Event or Problem Description
It was reported by the user facility that a patient underwent an unspecified procedure using a flexor shuttle select guiding sheath.The attending physician indicated that the entire valve broke off from the sheath once the device was initially removed from the product packaging and laid on the table.The device malfunction occurred prior to patient use.The device was replaced and the physician was able to complete the procedure.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Investigation - evaluation.Initial report corrected to 03/27/2015.Based on the information provided, and the results of our investigation, a definitive root cause could not be determined.

• Brand Name: FLEXOR SHUTTLE SELECT GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6291720
• Report Number: 1820334-2017-00238
• Device Sequence Number: 1021763
• Product Code: DYB
• UDI-Device Identifier: 00827002311381
• UDI-Public: (01)00827002311381(17)171014(10)5359852
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

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 Model Number: N/A
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-FLEX-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/03/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 06/16/2017
• Patient Sequence Number: 1