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

Model Number	PPLUS120
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during preparation for use in a therapeutic peripheral procedure, the pioneer plus catheter image was distorted and an error code "catheter fault ivacepi4090 detected.Please replace the catheter." was present.Due to no other similar devices available to compete the case endovascularly, the case was completed with surgical bypass.No patient injury reported.This adverse event and product problem is being submitted due to the device malfunction requiring surgical bypass to complete the procedure.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Age-ethnicity: no information available.Suspect products: not applicable for this device.Implant & explant date: not applicable for this device.Initial reporter reporting source: country is netherlands.The pioneer plus catheter was not returned for evaluation, thus no returned product investigation was performed.Remedial action & correction/removal reporting number: 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.
Additional Manufacturer Narrative
Block h3: the pioneer plus catheter was returned for evaluation.The catheter was connected to the pim and recognized by the imaging system; however, it displayed an incomplete image.Further testing identified an electrical failure along the scanner.Block h6: the probable cause of the reported complaint is likely the result of compromised connections.Strain, impact, and forces associated with use can affect the integrity of the electrical connections within 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.

• 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: 15048262
• Report Number: 3008363989-2022-00060
• Device Sequence Number: 20177664
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(11)220204(17)240204(10)5324206
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: 02/04/2024
• Device Model Number: PPLUS120
• Device Catalogue Number: 400-0200.246
• Device Lot Number: 5324206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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: UNK MFG AND SIZE: GUIDEWIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown