MAUDE Adverse Event Report: COOK INC APPROACH CTO MICROWIRE WIRE GUIDE; DQX WIRE, GUIDE, 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	03/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that during a left lower extremity angiogram, using an approach cto microwave wire guide, within two minutes of attempting to pass the cto, the tip of two approach cto microwire guides separated.The tip of the wires were still attached and able to be removed.The procedure was then completed using a competitor's wire.There was nothing left behind and no harm to the patient.This medwatch is for device lot #7638094, please see medwatch with mfr report# 1820334-2017-00556 for device lot #7611876.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, dimensional verification, device history record, instructions for use (ifu), specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.One approach cto microwire wire guide was returned to assist with the investigation.The wire is bent at 1.5 cm, 1.9 cm, 2.2 cm, and 2.6 cm from distal end.The coil is stretched at 3 mm from distal end and distal solder is present.The length of wire guide is 299.3 cm and diameter is.01360 inches.Both of these measurements are within specification.A document-based investigation evaluation was also 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: warnings - approach cto incorporates a stainless steel shaft with distal stainless steel and platinum coils and a hydrophilic floppy tip, used for general peripheral vascular interventions.The wire guide is a delicate instrument and should be handled carefully; forceful angulation should be avoided.The wire guide should be advanced only when visualizing the tip of the wire guide fluoroscopically.Carefully insert the distal tip of the wire guide through the insertion tool.The wire guide should not be torqued without evidence of corresponding movement of the distal tip.Upon removal from package, inspect the product to ensure no damage has occurred.Since this device is inspected 100% for bends, kinks, adequate joint strength, correct outside dimension and other surface imperfections prior to transport, it is plausible to suggest that the wire guide met with resistance during a procedurally related event, possibly inadvertent contact with the bevel of the needle during insertion and/or manipulation, or patient anatomy may have contributed as well.A definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: APPROACH CTO MICROWIRE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6461749
• Report Number: 1820334-2017-00553
• Device Sequence Number: 563884
• Product Code: DXQ
• UDI-Device Identifier: 00827002507913
• UDI-Public: (01)00827002507913(17)210805(10)7638094
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081337
• 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): 05/31/2017

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: CMW-14-300-12G
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1