MAUDE Adverse Event Report: COOK INC APPROACH CTO MICROWIRE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number N/A

Device Problem Difficult to Remove (1528)

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

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported that during a pta procedure on a (b)(6) year old male patient, they were unable to remove the approach cto microwire wire guide from another manufacturer's catheter.The patient's anatomy was very calcified and the approach cto microwire wire guide was inserted with some friction initially.When they attempted to remove the wire, it was fixed in another manufacturer's catheter.As a result, they removed the support catheter with the wire and completed the case.After the procedure, they attempted to push the wire out of the other manufacturer's catheter backwards but they were unsuccessful.They were only able to push the wire forward.Due to the amount of calcification, the patient was taken to surgery.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of complaint history, device history record, quality control, specifications, dimensional verification, trends, and visual inspection of the returned device was completed during this investigation.One used approach cto microwire wire guide was returned for investigation.The coil is detached from the core at the distal end and is elongated.Length and diameter of the wire guide are within specification.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation;,a definitive root cause could not be determined.

• Brand Name: APPROACH CTO MICROWIRE WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, 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: 6638609
• MDR Text Key: 77514829
• Report Number: 1820334-2017-01331
• Device Sequence Number: 1
• Product Code: DXQ
• UDI-Device Identifier: 00827002507913
• UDI-Public: (01)00827002507913(17)210611(10)7276889
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CMW-14-300-12G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• 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: 72 YR