MAUDE Adverse Event Report: VOLCANO CORPORATION PIONEER PLUS CATHETER; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number	PPLUS120
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.The pioneer plus catheter was returned for evaluation.Visual inspection found a bent scanner.During functional testing, the catheter was plugged into a laboratory intrasight system, was recognized; however, failed to produce an image.Further tests were performed, but also failed the wire bond, apt, and image tests.Block h6: the probable cause of the bent scanner was likely damaged during use/handling.Strain, impact, and forces associated with use can affect the integrity of the electrical connections within the device.Blocks h7, h9 & h10: 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.
Event or Problem Description
It was reported that an pioneer catheter was used in an emergent therapeutic peripheral procedure.During use, the catheter was defective.The procedure was completed with a new pioneer catheter.No patient injury report.This product problem is being reported because the catheter could not be used during an emergent case; resulting in a potential for harm due to the delay of the procedure.

• Brand Name: PIONEER PLUS CATHETER
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4125
• MDR Report Key: 21318117
• Report Number: 3008363989-2025-00015
• Device Sequence Number: 8697359
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(11)230301(17)250301(10)5509465
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

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: 03/01/2025
• Device Model Number: PPLUS120
• Device Catalogue Number: PPLUS120
• Device Lot Number: 5509465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: UNK MFG AND SIZE: GUIDEWIRE; UNK MFG AND SIZE: INTRODUCER SHEATH; UNK MFG AND SIZE: SYSTEM
• Patient Sex: Unknown