MAUDE Adverse Event Report: Volcano Corporation Pioneer Plus Catheter; Catheter For Crossing Total Occlusions

Model Number	PPLUS120
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a pioneer plus catheter was used in a peripheral procedure.During removal, it was noted that the distal tip separated but remained intact to the guidewire.The entire catheter was removed from the patient with no additional intervention required.No patient injury reported.This product problem is being submitted because the pioneer plus catheter tip separated.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a6: not available from facility.Blocks b6 & b7: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the pioneer plus catheter was returned without the distal tip.The returned section includes the scanner body, distal and proximal sleeve, and catheter shaft; measuring approx.119.3 cm in length from the strain relief.The overall measurement spec is 120 +/- 2cm, entire distal tip spec is approx.1.01 cm, which concludes that approx.0.7 - 1.01 cm was not returned.Block h6: the probable cause of the tip separation is likely due to handling during use.Manipulation, impact and applied pressure associated with use and handling can further affect the integrity of the device.Additionally, the device history record (dhr) was reviewed and all released units were manufactured to specification, with no ncrs or deviations contributing to the reported complaint.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 ; +1(858)720-4063
• MDR Report Key: 50779776
• Report Number: 3008363989-2026-00152
• Device Sequence Number: 16122226
• Product Code: PDU
• UDI-Device Identifier: 00845225003425
• UDI-Public: (01)00845225003425(11)250625(17)270625(10)5868505
• 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): 09/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PPLUS120
• Device Catalogue Number: PPLUS120
• Device Lot Number: 5868505
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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: Guide Wire, Mfg and Size Unk.; Introducer Sheath, Mfg and Size Unk.; Philips: IntraSight Mobile console.
• Patient Sex: Unknown