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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.The patient identifier was not available and the patient's race is hispanic.All reasonably known patient information is included in this report.Device evaluation anticipated, but not yet begun.(b)(4).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
It was reported that during a peripheral procedure, the manufacturer's catheter was advanced to the proximal sfa twice with no incident.Upon removal, x-ray showed the distal tip of the manufacturer's guide wire (approximately 10 inches long) broke off in the lower leg of the patient.A non-manufacturer's wire was advanced to the area and a gooseneck snare was used to retrieve the portion of the manufacturer's guide wire.Follow-up x-ray confirmed that no piece of the manufacturer's guide wire was retained in the patient.The patient was discharged and doing well.This adverse event is being submitted because the manufacturer's catheter is a concomitant device in use when the manufacturer's guide wire separated in the patient and required intervention.There is no allegation the manufacturer¿s catheter malfunctioned.
Additional Manufacturer Narrative
Internal reference: (b)(4).Block g3: initial mdr aware date listed (b)(6) 2021; however, correct date is (b)(6) 2021.Blocks h3 & h6: the phoenix catheter system was visually and microscopically inspected and did not appear damaged.In addition, component codes was intentionally left blank.There was no damage to the phoenix catheter system.

• Brand Name: PHOENIX CATHETER SYSTEM, 2.2MM X 149CM, 6F (KIT)
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11817171
• Report Number: 2939520-2021-00027
• Device Sequence Number: 3746890
• Product Code: MCW
• UDI-Device Identifier: 00845225002657
• UDI-Public: (01)00845225002657(17)230131(10)01222101
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172386
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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: 01/31/2023
• Device Model Number: P22149K
• Device Catalogue Number: 400-0200.293
• Device Lot Number: 02262112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHILIPS: 0.014" PHOENIX GUIDE WIRE; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH; PHILIPS: 0.014" PHOENIX GUIDE WIRE; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 68