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

Model Number	N/A
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
It was reported that during the retrieval of another manufacturer's filter, the physician used a 9frx45 sheath through an 11fr sheath.The physician snared the filter with the gooseneck snare and tried unsuccessfully to push the 9fr sheath over the filter.An 11fr overtop of the 9fr was then used to retrieve both the filter and the 9fr sheath.Upon examination of the removed parts it was determined that the tip of the sheath split completely open and the coiling was exposed.No additional products were needed to retrieve the defective product or to finish the procedure.The patient outcome will be determined when additional follow up is provided.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the complaint history, device history record, documentation, instructions for use (ifu), trends, quality control and photographic inspection of the device was conducted during the investigation.Five photos were returned for evaluation.Image #1 showed what appeared to be the complaint device tip ripped at the transition with a competitor filter and a complete separation of the sheath tubing proximal to the tip.There were exposed coil at the point of the tubing separation.Image #2 showed what appeared to be the dissection of the 11.0fr competitor sheath tubing.Image #3 appeared to show the complaint device inserted into an 11.0fr competitor sheath with no visible signs of sheath tubing damage at the point of insertion.The tubing of the snare showed extreme accordion-type characteristics where it was inserted into the check-flo valve.The complaint device was not returned therefore, no physical examinations could be performed; however, 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.The device is shipped with an instruction for use (ifu) that describes the intended use.Specific items addressed include: precautions: 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.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.The accordion-like characteristics of the snare tubing at the check-flo indicate that the snare was possibly too large for the sheath; possibly contributing to the observed material separation.However, without benefit of visual, dimensional, or functional testing of the device, a definitive rot cause cannot conclusively be determined.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.

• 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: 6060448
• Report Number: 1820334-2016-01218
• Device Sequence Number: 793961
• Product Code: DYB
• UDI-Device Identifier: 00827002491014
• UDI-Public: (01)00827002491014(17)190511(10)6963173
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/30/2016

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-9.0-18/38-45-RB-ANL0-HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2016
• Supplement Report FDA Received Date: 06/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other