MAUDE Adverse Event Report: PHILIPS VOLCANO ATHEROMED PHOENIX CATHETER SYSTEM, 2.2MM X 130CM, 6F (KIT); CATHETER, PERIPHERAL, ATHERECTOMY

Model Number P22130K

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information have been unsuccessful.Facility declined to provide the information.All reasonably known patient information is included in this report.Device lot number has not been provided by the customer thus expiration date and udi are unknown.Serial number is not applicable to this device.The implant or explant dates are not applicable to this device.Device was discarded at the customer site and not returned to manufacturer for analysis.Device was discarded at the customer site and not returned to manufacturer for analysis.Device lot number has not been provided by the customer thus manufacture date is unknown.

Event Description

It was reported during a therapeutic atherectomy procedure, the physician atherectomized the sfa and at successfully with the manufacturer's device.The physician redirected into peroneal in order to atherectomize the lesion at ostium of peroneal.There was a short, focal lesion with little to no vessel tortuosity.The physician went across the lesion twice and on the third pass the manufacturer's device wound down and was shut off by operator.The device was removed, angiogram was taken, and blush was visible at the bifurcation of peroneal/pt with no contrast filling either vessel distal to blush.Ballooned for five minutes in peroneal, took angiogram, and peroneal was back but blush was still visible/pt still not visible.Same balloon was used again in for 12 minutes and both peroneal and pt successfully filled with contrast and blush was no longer visible.Patient had a slight cramp in calf but said pain was dissipating.The physician was pleased with final angio as all tibial vessels were patent.As a precaution, patient was later admitted to hospital for evaluation and observation.The physician diagnosed patient with compartment syndrome and took patient to operating room that evening to perform a fasciotomy.This adverse event is being submitted because the manufacture's device was used in a procedure where the patient required medical and surgical intervention as well as hospitalization.

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient ethnicity have been unsuccessful.All reasonably known patient information is included in this report.Additional information provided the patient was transported to the hospital via ambulance; additional procedures performed: (b)(6) 2019: right calf exploration with ligation of right tibioperoneal trunk, posterior tibial and peroneal arteries.Fasciotomy of right posterior compartments.(b)(6) 2019: closure of right calf fasciotomy incision.The patients condition is reportedly stable.Inpatient, awaiting discharge to skilled nursing facility for further recovery.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 Description

This follow-up supplemental report #1 is being submitted to advise with additional information received.

• Brand Name: PHOENIX CATHETER SYSTEM, 2.2MM X 130CM, 6F (KIT)
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): PHILIPS VOLCANO ATHEROMED; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 9137960
• MDR Text Key: 166657104
• Report Number: 2939520-2019-00055
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): Y
• PMA/PMN Number: K140944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P22130K
• Device Catalogue Number: 400-0200.291
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 88