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	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturers policy.The probable cause of the observed failure is damage in use as evidenced by the lifted and missing material on the proximal section of the tip.Device manipulation, impact, and applied pressure associated with use and handling can further affect the integrity of 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: (b)(4).
Event or Problem Description
It was reported that during a peripheral procedure inside the body while advancing the lesion, the manufacturer's catheter lost image.The procedure was completed with a new manufacturer's catheter.No patient injury reported.The returned device was visually and microscopically inspected.A portion of the tip (approximately 0.25 square mm) was missing and lifted with rough edges of malleable shaft material.During functional testing, the device was recognized by the imaging system and produced an incomplete image.This product problem is being submitted because a portion of the manufacture's catheter 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 3123 (tip) 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: 11871541
• Report Number: 2939520-2021-00033
• Device Sequence Number: 3179814
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(17)221130(10)5042158
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 03/30/2021

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: 11/30/2022
• Device Model Number: PPLUS120
• Device Catalogue Number: 400-0200.246
• Device Lot Number: 5042158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/30/2021
• 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: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH