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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a patient underwent a peripheral intervention of the left sfa.During the procedure the wire guide snapped in two, while in the patient.Thus, the physician removed the product.There was not any harm to the patient and the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Product code: dqx.Investigation - evaluation: a review of the complaint history, dimensional verification, device history record,trends, and visual inspection of the device was conducted during the investigation.The visual examination confirmed separation of the approach cto microwire wire guide, piece one measuring from the distal tip approximately 39.5 cm in length.The it exhibited two kinks, measuring from the distal tip approximately 0.5 cm and 1.5 cm.The other piece measured 259.5 cm.Additionally, one of the ends of the polytetrafluoroethylene (ptfe) coated mandril wire appeared to show evidence that the wire was fractured.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.Based on the information provided and the results of the investigation, 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: 6054582
• Report Number: 1820334-2016-01157
• Device Sequence Number: 55442
• Product Code: DXQ
• UDI-Device Identifier: 00827002507906
• UDI-Public: (01)00827002507906(17)210428(10)7027137
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2016

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-14-300-6G
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1