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

Model Number	PPLUS120
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information have been unsuccessful.No information available.The implant or explant dates are not applicable to this device.Not applicable for this device.No information available.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 the alleged death or deterioration in the state of the health of any person.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer¿s policy.It was reported during a planned therapeutic peripheral procedure, the manufactures device could not be removed from another manufactures wire device during pullback, both wire and catheter were removed together, all pieces intact.The manufactures device was re-introduced with a new wire.No patient injury.The device was returned to the manufacture with no wire stuck to/in it.The returned device was visually and microscopically inspected and damage was observed.The scanner body was slightly bent; no sharp or rough edge were observed.The rx exit port was torn and stretched; a small portion of rx exit port material was missing from the device.It could not be conclusively determined when and how the rx exit port was damaged.This product problem is being submitted because the returned device was missing material.There is a potential for harm if the malfunction were to recur.

• Brand Name: PIONEER PLUS PPLUS120
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11064717
• Report Number: 2939520-2020-00039
• Device Sequence Number: 2651800
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(17)220930(10)4982963
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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: 09/30/2022
• Device Model Number: PPLUS120
• Device Catalogue Number: 400-0200.246
• Device Lot Number: 4982963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1