MAUDE Adverse Event Report: PHILIPS VOLCANO PIONEER PLUS PPLUS120; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number	PPLUS120
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.The pioneer plus catheter was returned and visually and microscopically inspected.The distal tip, the scanner and a portion of the distal sleeve were detached and not returned.A zippered tear was noted starting from the rx exit port to the distal sleeve and as a result, polyamide was exposed with rough edges of malleable material.The needle was present and completely inside the needle exit port; however, it was stuck and unable to be retracted or deployed.The probable cause for the tip separation is damage occurred during use due to excess force.Device manipulation, impact and applied pressure 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 during a therapeutic peripheral procedure in a severely calcified mid sfa, when loading the manufacturer''s catheter onto the guidewire, resistance was encountered.The catheter was taken out, re-flushed and re-loaded onto the guidewire with no resistance.Then, the re-entry needle was deployed in the target vessel and a re-entry guidewire was inserted through the re-entry needle and into the target vessel, but did not pass easily.Then the re-entry guidewire was pulled back and the needle was retracted (unclear if it was fully retracted).An attempt was made to pin/pull the catheter out over the re-entry guidewire; however, resistance was encountered.The physician pulled harder on the catheter and upon removal, it was observed that the tip of the catheter had broken off.Under fluoroscopy, the separated tip was observed near the re-entry site in the subintimal space outside of the target lesion.The patient was hospitalized and taken to the or for retrieval of the device; however, the separated tip was unable to be retrieved.The vessel was stented to cover the subintimal space where the separated portion of the tip was located and jailed in the vessel wall.The patient was discharged back to the facility.This adverse event and product problem is being submitted because the distal tip of the manufacturer''s catheter separated.Additional intervention was performed; however, the separated tip was retained in the patient.

• Brand Name: PIONEER PLUS PPLUS120
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: ayse yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 13970841
• Report Number: 3008363989-2022-00020
• Device Sequence Number: 4611865
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(11)211223(17)231223(10)5207827
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/23/2023
• Device Model Number: PPLUS120
• Device Catalogue Number: 400-0200.246
• Device Lot Number: 5207827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2021
• 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: ASAHI: 0.014¿ REGALIA GUIDEWIRE; ASAHI: 0.014¿ REGALIA RE-ENTRY GUIDEWIRE; TERUMO: 6FR DESTINATION INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White