MAUDE Adverse Event Report: COOK INC FLEXOR SHUTTLE SELECT GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a left internal carotid stenting, access transfemoral right side procedure using a flexor shuttle select guiding sheath, the physician reported that the flexor at the hub was very flexible and unstable.It did not appear to be sealed allowing blood to flow out.It was reported that the flexor got separated from the rest of the product.A section of the device did not remain inside the patient¿s 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
A review of the complaint history, device history record, documentation, drawing, instructions for use, quality control, and visual inspection of the returned device were conducted during the investigation.One used flexor shuttle select guiding sheath and dilator were returned for evaluation.Visual inspection revealed that the sheath was partially disconnected from the hub.It was connected only by exposed coil.The flare of the sheath was retained inside the hub.Distal tip of the sheath tubing was wrinkled.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 states the proper warnings, precautions, and instructions for use: "standard techniques for placement of vascular access sheaths should be employed." "the maximum diameter of the instrument or catheter to be introduced should be determined to ensure its passage through the introducer.All instruments or catheters used with this product should move freely through the valve and sheath.Damage to the valve/introducer may result when the fit is tight." "do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Based on the information provided, a definitive root cause could not conclusively be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.A review of the complaint history, device history record, documentation, drawing, instructions for use, quality control, and visual inspection of the returned device were conducted during the investigation.One used flexor shuttle select guiding sheath and dilator were returned for evaluation.Visual inspection revealed that the sheath was partially disconnected from the hub.It was connected only by exposed coil.The flare of the sheath was retained inside the hub.Distal tip of the sheath tubing was wrinkled.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 states the proper warnings, precautions, and instructions for use: "standard techniques for placement of vascular access sheaths should be employed." "the maximum diameter of the instrument or catheter to be introduced should be determined to ensure its passage through the introducer.All instruments or catheters used with this product should move freely through the valve and sheath.Damage to the valve/introducer may result when the fit is tight." "do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Based on the information provided, a definitive root cause could not conclusively be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.

• 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: 6593540
• Report Number: 1820334-2017-00986
• Device Sequence Number: 10786998
• Product Code: DYB
• UDI-Device Identifier: 00827002311381
• UDI-Public: (01)00827002311381(17)191209(10)7504733
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

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: 04/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 69