MAUDE Adverse Event Report: VOLCANO ATHEROMED, INC 2.2MM X 149 CM PHOENIX ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P22149K
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	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reasonably known patient information is included in this report.Additional information provided, attempt(s) to retrieve the guidewire (another manufacturer's device) were unsuccessful.The guidewire was left in situ, secured in a side branch (tibial collateral/side branch, not flow limiting.) the manufacturer's device and proximal portion of the guidewire were removed as a system.No tests/laboratory data was available.No information was available.This "blank" is not an omission.There is no serial number associated with this product; it is referenced by lot number.This "blank" is not an omission.The implant or explant dates are not applicable to this device.The manufacturer's device was returned for analysis.The guidewire (another manufacturer's device) was returned along with the manufacturer's device.The manufacturer's device handle and catheter were both undamaged.Neither the handle or catheter showed signs of wear.There was no indication of negative wire interaction with the manufacturer's device.As evidenced by the cutter head and catheter shaft being intact with no deformation.Additionally, no portions of the guide wire were in the cutter head or stuck within the catheter shaft which would be present had the cutter head come into contact with the wire.The guidewire was inspected.It showed no signs of wear or abrasion on the wire surface.The distal end of the wire was found to be broken at the wire core.This break does not appear to be a torsional failure which would be evident if there were negative wire interaction with rotational atherectomy.It is possible that "while stuck" in the tibial vessel the wire was manipulated in a way that severely damaged it which eventually led to wire separation at the distal guidewire core.There is no evidence that the guidewire was damaged by manufacturer's device.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
This case was investigated according to the manufacturer's policy.It was reported, the manufacturer's device caused the guidewire (another manufacturer's device) to break inside the patient.The guidewire broke at the distal end.The guidewire was left behind inside the patient.A second device (another manufacturer's device) was used to complete the procedure.The patient was reportedly released in "good" condition.Other devices in use: cook.014 300 cm roadrunner.Vessel: superficial femoral artery (sfa).This event is being reported because a portion of the guidewire (another manufacturer's device) separated in the patient while the manufacturer's device was in use.The separated portion of the guidewire remains in the patient.

• Brand Name: 2.2MM X 149 CM PHOENIX ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): VOLCANO ATHEROMED, INC; 1530 o'brien drive, suite a; menlo park CA 94025
• MDR Report Key: 7729259
• Report Number: 2939520-2018-00072
• Device Sequence Number: 1269470
• Product Code: MCW
• UDI-Device Identifier: 00845225002657
• UDI-Public: (01)00845225002657(17)200131(10)12181717
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K143328
• 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): 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: P22149K
• Device Catalogue Number: 400-0200.293
• Device Lot Number: 12181717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/27/2018
• 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
• Patient Age: 72 YR