MAUDE Adverse Event Report: PHILIPS VOLCANO PHOENIX CATHETER SYSTEM, 2.2MM X 149CM, 6F (KIT); CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P22149K
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a phoenix catheter was used in a therapeutic peripheral procedure in a moderately calcified lesions.The catheter was loaded over a phoenix guidewire, and inserted through a non-philips introducer sheath.The phoenix catheter was turned on, and used back and forth in multiple mixed focal lesions into the sfa and popliteal artery.After the 3rd pass, the battery began to die within 10 minutes.The battery was exchanged, but the device would not turn on.Therefore, the physician decided to remove the catheter since the procedure was almost completed.During pullback, resistance was encountered and required the catheter to be manipulated back and forth.The catheter finally loosened up and was able to be removed from the patient.Upon removal, a broken shaft was noted exposing the inner archimedes screw.Ivus was performed and confirmed the vessels were fine, and the atherectomy was successful.No patient injury reported.Device analysis confirmed a break at the outer laser cut shaft, which has the potential to have a sharp edge due to the material being non-malleable.This product problem is being submitted in abundance of caution, because of the potentially sharp edge at the location of the break.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.No information available.No information available.Not applicable for this device.Serial number not applicable for this device.Not applicable for this device.The phoenix catheter was visually and microscopically inspected.The catheter shaft (includes outer laser cut and ptfe lining) was broken at approximately 255mm from the distal end, exposing the archimedes screw.The outer laser cut shaft is a non-malleable material and has the potential to have a sharp edge.Additionally, several kinks were observed near the location of the break.There were no missing pieces noted.Based on the complaint description and the multiple kinks observed on the shaft, the user made 3 passes, which could have resulted in one of the kinks potentially breaking during use or removal from the calcified lesion.Do not apply to this submission.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 an alleged death or deterioration in the state of the health of any person.
Additional Manufacturer Narrative
Blocks a2-5: patient date of birth, age at time of event, gender, weight, ethnicity and race available.Block b6: relevant tests/laboratory data available.Block b7: other relevant history, including preexisting medical conditions available.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 an alleged death or deterioration in the state of the health of any person.

• Brand Name: PHOENIX CATHETER SYSTEM, 2.2MM X 149CM, 6F (KIT)
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): PHILIPS VOLCANO; 1530 o brien drive, suite a; menlo park CA 94025
• Manufacturer (Section G): VOLCANO ATHEROMED, INC.; 1530 o brien drive, suite a; menlo park CA 94025
• Manufacturer Contact: ayse yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 16438925
• Report Number: 3008847191-2023-00001
• Device Sequence Number: 7400860
• Product Code: MCW
• UDI-Device Identifier: 00845225002657
• UDI-Public: (01)00845225002657(17)240731(10)07012102
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K172386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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: 07/31/2024
• Device Model Number: P22149K
• Device Catalogue Number: 400-0200.293
• Device Lot Number: 09082125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHILIPS: 0.014" PHOENIX GUIDEWIRE; TERUMO: 6F DESTINATION INTRODUCER SHEATH
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White