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

Model Number	PPLUS120
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.(b)(6).The pioneer plus catheter has not been returned for evaluation, thus no returned product investigation was performed.
Event or Problem Description
It was reported that during a therapeutic peripheral procedure, while using the manufacturer's catheter, there was a grainy ultrasound image.The manufacturer's catheter was placed at the re-entry site in the distal sfa.During advancement of the needle on the second attempt, resistance was noted.Then, the non-manufacturer's re-entry wire was successfully inserted into the true lumen.However, during removal, the manufacturer's catheter can only be withdrawn together with the non-manufacturer's wire.After multiple manipulations, the occlusion could lengthen and the lower leg may have an even poorer arterial blood supply.The procedure was completed with a new device.No patient injury reported.This adverse event is being submitted out of abundance of caution.Based on the information received, it could not be determined if re-occlusion in the lower leg occurred during use of the manufacturer's catheter.
Additional Manufacturer Narrative
Block b5: this event is no longer reportable as stated in supplemental mdr #1 submitted on (b)(6) 2021.Block h3: the pioneer plus catheter was visually and microscopically inspected.Visual inspection found no damage that could have led to the reported failure.During functional testing, a guidewire movement test was performed using a 0.0150¿ mandrel.The mandrel passed from the distal tip to the exit port with no resistance encountered.The reported failure of removal as a system could not be confirmed.Block h6: a probable cause could not be determined since there was no damage observed that could have led to the reported failure.
Event or Problem Description
For clarification, there was no re-occlusion in the lower leg, or intervention, or patient injury, or status decline in the patient's health.Additionally, the returned manufacturer's device was evaluated and confirmed there was no damage observed that could have led to the device being removed as a system (no intervention).Since the reported device malfunction could not be replicated, there is no potential for harm.
Additional Manufacturer Narrative
Block b5: this event is no longer reportable per the additional information received.There was no lengthening of the occlusion.
Event or Problem Description
Initial mdr reported a re-occlusion out of abundance of caution.However, per the additional information received on 11/15/2021, the occlusion did not lengthen.Therefore, this event is no longer reportable.

• 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: 12784312
• Report Number: 3008363989-2021-00024
• Device Sequence Number: 5155803
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(11)210322(17)230322(10)5118873
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K162418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2023
• Device Model Number: PPLUS120
• Device Catalogue Number: 400-0200.246
• Device Lot Number: 5118873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2021
• 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: 10/26/2021
• Supplement Date Received by Manufacturer: 11/15/2021; 11/25/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 11/30/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• 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.; UNK MFG AND SIZE: RE-ENTRY WIRE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown