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

Model Number	G50793
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx (b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during a superficial femoral artery (sfa) angioplasty, while advancing the approach cto microwire wire guide into the sheath, the coating was observed to be coming off.The wire guide was exchanged and the procedure was successfully completed.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.
Additional Manufacturer Narrative
Concomitant medical products:.018 cxi.A competitor's torque device.Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.Upon the removal of the cap from the torque device, the visual inspection of the returned device confirmed the presence of green flakes inside the cap, as well as the distal end of the base of the torque device.Bends were noted 4 mm and 1 mm from the distal end.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed 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 ifu for the product states" approach hydro st wire guide should never be used in conjunction with or through a metal needle cannula.Avoid manipulating or withdrawing the wire guide back through a metal needle or cannula.A sharp edge may scrape the coating or shear the wire guide.Excessive tightening of the torque device (if provided) on to the wire guide may result in a abrasion of the coating of the wire guide.Always flush the hydro st before use.Always maintain a wet surface on the hydrophilic portion of the hydro st for optimal results.Flush the wire guide holder be attaching or pressing a syringe with heparinized saline or sterile water to the fitting of the wire guide holder and injecting enough solution to wet the wire guide surface entirely.Upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was determined to be related to the use or handling of the product.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: 7110697
• Report Number: 1820334-2017-04485
• Device Sequence Number: 1358033
• Product Code: DQX
• UDI-Device Identifier: 00827002507937
• UDI-Public: (01)00827002507937(17)220224(10)8333327
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/08/2018

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: G50793
• Device Catalogue Number: CMW-14-300-25G
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1