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

Model Number	PPLUS120
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
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 intact to a non-philips guidewire.Visual inspection found a retracted needle and a portion of the distal sleeve lifted.During functional testing, an attempt was made to remove the guidewire, but could not be removed.Additionally, a needle deployment/retraction test was performed; however, it failed due to resistance.Although the needle was retracted when received for evaluation, the customer confirmed that the needle was exposed when removed from the patient.Block h6: the probable cause of the needle unable to deploy/retract is due to mechanical failure.Device manipulation, impact, and handling can further affect the integrity of 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 a pioneer plus catheter was used in a therapeutic peripheral procedure.During use, the needle was unable to retract.A new catheter was used to complete the procedure.No patient injury reported.Additional information obtained on 03oct2025: after several attempts to retract the needle, the decision was made to remove the entire system from the patient.After removal, the catheter was manipulated multiple times and was finally able to retract the needle.This product problem is being submitted due to a sharp edge.There is a potential for harm if the malfunction was to recur.
Additional Manufacturer Narrative
Block d10: received guidewire, introducer sheath, and guide catheter manufacturer name and size.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: ana tan ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4037
• MDR Report Key: 23294350
• Report Number: 3008363989-2025-00123
• Device Sequence Number: 17340094
• Product Code: PDU
• UDI-Device Identifier: 00845225003425
• UDI-Public: (01)00845225003425(11)250527(17)270527(10)5847849
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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 Model Number: PPLUS120
• Device Catalogue Number: PPLUS120
• Device Lot Number: 5847849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2025
• 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: ABBOTT: 0.014" COMMAND GUIDEWIRE.; CORDIS: 4F AQUA GUIDE CATHETER.; PHILIPS: IVUS SYSTEM.; TERUMO: 6F INTRODUCER SHEATH.; UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: GUIDEWIRE.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Patient Sex: Unknown