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

Model Number	N/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The reported device is not available for evaluation and has been discarded.
Event or Problem Description
It was reported that during a right leg lower extremity angiogram procedure with an approach cto microwire wire guide, the tip separated.The physician was trying to cross a highly calcified lesion in the popliteal artery.The wire went subintimal.It was now outside the artery.When the physician pulled it back, the tip separated.This left about 15 mm of the wire inside the patient.The physician did not attempt to retrieve it.The unintended section of the device remained inside the patient's body.The patient did not undergo any additional procedures and no adverse effects were reported due to this occurrence.
Additional Manufacturer Narrative
Corrected information: unintended fragment implanted, dqx, investigation - evaluation: a review of the complaint history, drawings, device history record, instructions for use (ifu), and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.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 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: 6724444
• Report Number: 1820334-2017-01636
• Device Sequence Number: 531794
• Product Code: DXQ
• UDI-Device Identifier: 00827002507937
• UDI-Public: (01)00827002507937(17)200820(10)6412414
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

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: 06/21/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 08/09/2017
• 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: Other
• Patient Age: 73 YR