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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.No information available.Not applicable for this device.Not applicable for this device.The probable cause of the reported failure is damage in use as evidenced by a bend on the scanner.Strain, impact, and forces associated with use can affect the integrity of the electrical connections within the device.In addition, the health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter code: 2199 (no health consequences or impact).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
It was reported that during a peripheral procedure inside the body while passing through the lesion, the manufacturer's catheter's image was incomplete and 3/4 of the image was blacked out.The procedure was completed with a different device.No patient injury reported.The returned device was visually and microscopically inspected.A portion of the distal shaft (less than 0.25 square mm) was missing and lifted approximately 26 mm from the distal tip with rough edges of malleable shaft material.During functional testing, the device failed to be recognized by the imaging system and the system and displayed a ¿no catheter¿ message.This product problem is being submitted because a portion of the manufactured's device was missing.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Internal reference: (b)(4).Block h6: added codes 4721 (rod/shaft) and 2199 (no health consequences or impact).

• 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: 11845096
• Report Number: 2939520-2021-00029
• Device Sequence Number: 3142509
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(17)221031(10)5041116
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K152829
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: 10/31/2022
• Device Model Number: PPLUS120
• Device Catalogue Number: 400-0200.246
• Device Lot Number: 5041116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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: BOSTON SCIENTIFIC: 0.018" PLATINUM PLUS GUIDE WIRE; TELEFLEX: 4F VSI MICRO KIT INTRODUCER KIT; TERUMO: 6F PINNACLE DESTINATION GUIDE/SHEATH
• Patient Age: 67 YR
• Patient Weight: 47