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

Model Number	PPLUS120
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h3: the pioneer plus catheter was returned without the non-philips guidewire.Visual inspection found a damaged rx exit port, which aligns with the reported complaint that a bump was present on the monorail (exit port).During functional testing, the catheter failed the guidewire movement test due to resistance encountered.Block h6: the probable cause of the reported failure (removal as a system) is damage during use/handling.Manipulation, strain, impact, and applied force associated with use and handling can further affect the integrity of the device.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 a pioneer plus catheter was used for a peripheral procedure in a severely calcified sfa.During advancement, the catheter got stuck on the non-philips wire; therefore, removed as a system.Additionally, it was noted that the catheter had a bump on the monorail, where the wire comes out.A new pioneer catheter was used to complete the procedure with no patient injury reported.This product problem is being submitted because the pioneer plus catheter and guidewire were removed as a system.There is potential for harm if it were to recur.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block a3b: not provided by the facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the pioneer plus catheter was not returned, thus no product investigation performed.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.

• 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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 24300444
• Report Number: 3008363989-2026-00017
• Device Sequence Number: 14768856
• Product Code: PDU
• UDI-Device Identifier: 00845225003425
• UDI-Public: (01)00845225003425(11)250721(17)270721(10)5906249
• 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,Followup
• Report Date (Section B): 03/27/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: PPLUS120
• Device Catalogue Number: PPLUS120
• Device Lot Number: 5906249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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: 0.014", ROADRUNNER GUIDE WIRE.; PHILIPS: CORE M2 CONSOLE.; TERUMO: 6F, PINNACLE DESTINATION INTRODUCER SHEATH.
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White