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

Model Number	PPLUS120
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: 149548 : attempts to obtain patient information are unsuccessful.Attempts to obtain the patient information were made via email.All reasonably known patient information is included in this report.No information available.Serial number is not applicable to this device.The implant or explant dates are not applicable to this device.Not applicable for this device.Device not returned to manufacturer for analysis.Do not apply to this submission.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.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 after a therapeutic peripheral procedure, outside patient, after use, the needle of the manufactures device was not fully retracted.There was no unscheduled intervention required to remove the device, no adverse events and no patient injury.Additional information provided, no damage was noted to the device during preparation; practice firing of needle was done and needle retracted completely when tested.Device was inserted into the patient once, needle had been fired twice and removed without any difficulty along with another manufactures wire device due to the wire kinking outside the body.A second of the manufactures same device was used to successfully complete the procedure.Lesion was 100% occlusion in the proximal anterior tibial (at), normal tortuous anatomy for at take off, moderate calcification present.Patient was discharged as expected in "good" condition.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being submitted because the needle reportedly did not fully retract into the device.There is a potential for harm if the malfunction were to recur.
Event or Problem Description
This follow-up supplemental report #1 is being submitted to advise pertinent device analysis findings.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer's policy.Block h3: the device was visually and microscopically inspected, functional testing was performed.The needle was fully extended and then retracted completely into the catheter when tested, no issues were observed.The probable cause of the reported failure could not be determined by the investigation as the device passed functional testing, and no damage or faults that could lead to the reported failure were observed.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.

• 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: 11072032
• Report Number: 2939520-2020-00041
• Device Sequence Number: 2850056
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(17)220930(10)5012730
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 12/11/2020

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: 5012730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/24/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK ANSEL SHEATH, GRAND SLAM WIRE; COOK ANSEL SHEATH, GRAND SLAM WIRE
• Patient Weight: 91