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	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
It is alleged that an approach cto microwire wire guide was being used in the superficial femoral artery of a patient when the tip of the wire broke off.It was reported that the patient had noticeable calcification and after shaping the tip of the wire, the tip separated and was "lost" in the calcification.The fractured piece of the wire was unable to be retrieved.As per the company representative, the physician was not able to reach the lesion due to the calcification, and the patient received a vascular bypass as a result.No adverse events have been reported regarding this incident.
Additional Manufacturer Narrative
Product code: dqx.Investigation - evaluation: a review of the complaint history, drawings, device history record, instructions for use (ifu), specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.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, no product returned, and the results of our investigation; a definitive root cause could not be determined.We will notify the appropriate personnel and 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: 6744518
• Report Number: 1820334-2017-01872
• Device Sequence Number: 16306842
• Product Code: DXQ
• UDI-Device Identifier: 00827002507937
• UDI-Public: (01)00827002507937(17)210611(10)7357552
• Combination Product (Y/N): N
• PMA/510(K) Number: K081337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CMW-14-300-25G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention