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	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a pioneer plus catheter was used in a peripheral procedure, in a slightly calcified and fibrous lesion.During re-entry, the needle was unable to be deployed.Therefore, the catheter was removed but got stuck on the non-philips guidewire, and removed as a system.Upon removal, the rapid exchange port was damaged.Another pioneer catheter was used to complete the procedure with no patient injury reported.During the product return evaluation, it was found that the polyamide material was separated from the catheter, but remained intact to the non-philips guidewire.This product problem is being submitted due to material separation.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.A2-a5: no information available.B6 & b7: no information available.C: not applicable for this device.D6 & d7: not applicable for this device.H3: the pioneer plus catheter was returned stuck onto a non-philips guidewire at the rx port.Visual inspection found a zipper tear from the rx exit port to the distal sleeve, and measured approximately 6 cm in length.In this area, the microcables were exposed and broken with sharp edges observed, but were contained within the shaft material.A portion of the polyamide material was bunched up and separated from the catheter, but was intact to the guidewire.No missing material was detected within the catheter working length.H6: the probable cause of the material separation likely occurred during use/handling.Manipulation, strain, impact, and forces associated with use can affect the integrity of the device.H7 & h9: 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: 18899864
• Report Number: 3008363989-2024-00018
• Device Sequence Number: 15737114
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(11)220707(17)240707(10)5377955
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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: 07/07/2024
• Device Model Number: PPLUS120
• Device Catalogue Number: PPLUS120
• Device Lot Number: 5377955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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: SIZE 0.014", MFG UNK; INTRODUCER SHEATH MFG AND SIZE UNK
• Patient Sex: Unknown