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

Model Number	P22149K
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.This resulted in user error.During use in patient, the user ran the catheter inside the sheath, resulting in the foreign plastic material wedged in between the cutter head.Ifu states, the phoenix system must be off while advancing forward through the introducer sheath.
Event or Problem Description
It was reported that during a therapeutic peripheral procedure after treatment, the manufacturer's catheter was stuck on the manufacturer's guide wire and was unable to be removed in a pin/pull fashion.During removal the manufacturer's catheter was run briefly in the sheath to track backwards off the manufacturer's guide wire but remained stuck; therefore, it was removed as a system.The procedure was completed with a non manufacturer's balloon with no patient injury reported.During the return product evaluation, foreign plastic material from the non manufacturer's introducer sheath was observed on the cutter head.This product problem is being submitted as concomitant usage due to the foreign plastic material observed on the manufacturer's catheter.There is potential for harm with recurrence.
Additional Manufacturer Narrative
Block h6: added investigation conclusion code 18.

• Brand Name: PHOENIX CATHETER SYSTEM, 2.2MM X 149CM, 6F (KIT)
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): VOLCANO ATHEROMED, INC.; 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 95670
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive; #500; san diego, CA 92130
• MDR Report Key: 12872824
• Report Number: 3008847191-2021-00002
• Device Sequence Number: 4662020
• Product Code: MCW
• UDI-Device Identifier: 00845225002657
• UDI-Public: (01)00845225002657(17)240331(10)03232107
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/07/2021

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: 03/31/2024
• Device Model Number: P22149K
• Device Catalogue Number: 400-0200.293
• Device Lot Number: 05042104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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: COOK: 6F INTRODUCER SHEATH; LAKE REGION MEDICAL: 0.014 GUIDE WIRE; UNK MFG AND SIZE: GUIDE CATHETER
• Patient Sex: Unknown