MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX 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	04/27/2017
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 lower extremity agram with atherectomy and percutaneous transluminal angioplasty (pta) procedure using a flexor high-flex ansel guiding sheath, the hub separated.It was reported that the procedure was completed and the physician went to remove the 8f ansel sheath from the pts right groin.He pulled from the check flo hub with minimal force and the hub separated clean from the body of the introducer, exposing the flared end of the 8f introducer.The physician was still able to safely remove the sheath from the patient without issue.No additional procedures were required.It was reported that the patient's tissue was scarred and the physician did not re-introduce the sheath's inner dilator prior to removing.The patient was not harmed in any way and no additional procedures were required.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, dimensional verification, documentation, instructions for use (ifu), manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.One used flexor high-flex ansel guiding sheath was returned with the proximal hub separated from the sheath.No notable damage observed on the sheath tubing.The dilator was not returned.Sheath flare passed through the large hole and did not pass through small hole of go/no-go flare gauge.The connector cap accepted a 0.150" pin gauge.Review of the device history record shows no nonconforming events which could contribute to this failure mode.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: precaution: "this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of vascular access sheaths should be employed." "do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt." "withdraw the sheath and dilator as a unit." the site reported that the physician did not reintroduce the sheath's inner dilator prior to removal.The ifu instructs the user to withdraw the sheath and dilator as a unit.Based on the available information and results of the investigation the most likely root cause may be related to the patient's pre-existing clinical condition (scarred tissue), and user technique during the procedure.Per the quality engineering risk assessment no further action is required.Monitoring for similar complaints will continue.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6593883
• Report Number: 1820334-2017-00931
• Device Sequence Number: 1148378
• Product Code: DYB
• UDI-Device Identifier: 00827002562332
• UDI-Public: (01)00827002562332(17)190721(10)7137516
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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: KCFW-8.0-35-55-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1