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

Model Number	PPLUS120
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a therapeutic peripheral procedure, the manufacturer's catheter's needle did not deploy.A second manufacturer's catheter was used to complete the procedure.No patient injury was reported.The returned device was visually and microscopically inspected.The needle was slightly protruded, presenting a sharp edge.This product problem is being submitted for the protruding needle.There is a potential for harm if the malfunction were to reoccur.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.The probable cause is a mechanical failure due to the needle unable to deploy fully.Device manipulation, impact and applied pressure associated with use and handling may affect the integrity of the device.

• 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 par; b37; alajuela ; CS
• Manufacturer Contact: in young rock ; 3721 valley centre drive; #500; san diego, CA 92130
• MDR Report Key: 12840692
• Report Number: 3008363989-2021-00025
• Device Sequence Number: 19894933
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(17)221031(10)5041118
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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: 5041118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• 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: 11/03/2021
• Initial Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• 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
• Patient Sex: Unknown