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

Catalog Number KCFW-8.0-35-55-RB-HFANL1-HC

Device Problems Kinked (1339); Stretched (1601); Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that prior to patient contact, the sheath was noted to be kinked.Device imaging identified slight stretching and a sharp edge at the location of the kink.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, instructions for use (ifu), and quality control data was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Per the instructions for use (ifu), t_intro_rev2, states, "warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.Precautions: 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.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.Sheath removal: insert wire guide at least 10 cm past the tip of the sheath.Insert the dilator over the wire into the sheath.Withdraw the sheath and dilator as a unit.Remove the wire guide." based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6730621
• MDR Text Key: 80625302
• Report Number: 1820334-2017-01800
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KCFW-8.0-35-55-RB-HFANL1-HC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 DA
• Patient Weight: 75