MAUDE Adverse Event Report: PHILIPS VOLCANO PHOENIX CATHETER SYSTEM, 1.8MM X 130CM, 5F (KIT); CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P18130K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Muscle Spasm(s) (1966)
Date of Event	11/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information are unsuccessful.Attempts to obtain the patient information were made via email.All reasonably known patient information is included in this report.Additional information obtained indicated manufacturers catheter device performed as intended.This was the second pass, at the end of the procedure, the wire was brand new.The patient had significant spasm as the manufacturers device was being removed and the wire malfunctioned.Vessel was ballooned but the distal end of the wire remained in the dorsalis pedis.Once wire was removed it was apparent the wire had sheared off in the lumen of the artery.There was no obvious damage to the manufacturers device.The patient was sent to the hospital and a focal open procedure was performed the following day to remove the wire from the dorsalis pedis.The patient was discharged and is reportedly ambulatory and in good spirits.No information available.The implant or explant dates are not applicable to this device.Recall: not applicable for this device.Concomitant medical products: phoenix guide wire, 11cm cordis access sheath.Device not returned to manufacturer for analysis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
It was reported during a planned therapeutic peripheral procedure, another manufacturer's wire device broke off in the patient.The tip was retrieved one day after the case.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Subject device has been returned to the manufacturer, analysis is in progress.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
Event or Problem Description
This follow-up supplemental report #1 is being submitted to advise the subject device has been returned to the manufacturer, analysis is in progress.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block b5: there is no allegation the manufacturers malfunctioned.The device was investigated based on concomitant usage during an adverse event.Block h3: the device was visually examined and functionally tested.The device was found to be undamaged with no obstruction in the guidewire lumen.The cutter head was intact, the knob worked as designed (rotated freely) and the handle operated normally.Due to the undamaged condition of the device, the complaint could not be confirmed nor a probable cause determined as to how the concomitant wire was damaged resulting in the adverse event.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
Event or Problem Description
This follow-up supplemental report #2 is being submitted to advise pertinent device analysis findings.

• Brand Name: PHOENIX CATHETER SYSTEM, 1.8MM X 130CM, 5F (KIT)
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 10901162
• Report Number: 2939520-2020-00036
• Device Sequence Number: 1461985
• Product Code: MCW
• UDI-Device Identifier: 00845225002619
• UDI-Public: (01)00845225002619(17)211031(10)09301901
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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,Followup,Followup
• Report Date (Section B): 11/12/2020

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: 10/31/2021
• Device Model Number: P18130K
• Device Catalogue Number: 400-0200.290
• Device Lot Number: 10281908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/31/2020; 01/29/2021
• 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: Hospitalization; Required Intervention