MAUDE Adverse Event Report: ATHEROMED INC 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P22130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts to obtain patient information have been unsuccessful.Attempts to obtain the patient information were made via email and phone.All reasonably known patient information is included in this report.Additional information obtained indicated no damage was observed during prep.Additionally it was reported the manufacturer device did not fail.No tests/laboratory data was available.No information was available.There is no serial number associated with this product; it is referenced by lot number the implant or explant dates are not applicable to this device.No physical product investigation was possible as the device was not returned.Per the manufacturer's instructions for use (ifu): precautions: - hold the proximal end of the guidewire securely with a torque device when the handle is on.Failure to do so may result in guidewire rotation and/or loss of position within the vessel.Adverse effects: - fracture of any component of the device that may or may not lead to serious injury or surgical intervention.
Event or Problem Description
This case has been investigated in accordance with the manufacturers policy.It was reported that during the procedure while removing the manufacturers device, over the cook wire, the tip of the wire broke off in an occluded peroneal artery.The physician elected not to attempt intervention to remove the wire fragment as it was in an occluded artery with no additional clinical sequela.The physician performed an adjunctive percutaneous transluminal angioplasty (pta) to complete the procedure.The patient's treatment was completed by this procedure with the patient discharged as expected.Vessel: sfa/pop and tpt.Other devices in use: cook roadrunner lot# 7405229.

• Brand Name: 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): ATHEROMED INC; 1455 adams drive, suite 1120; menlo park CA 94025
• MDR Report Key: 6302675
• Report Number: 2939520-2017-00013
• Device Sequence Number: 780840
• Product Code: MCW
• UDI-Device Identifier: 00845225002626
• UDI-Public: (01)00845225002626(17)180930(10)09131619
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K140944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: P22130
• Device Catalogue Number: P22130K
• Device Lot Number: 09131619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 02/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1