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	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Age, weight& ethnicity: no information available.Blocks implant date & explant date: not applicable for this device.The pioneer plus catheter has not been returned for evaluation, thus no returned product investigation was performed.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 an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
It was reported that during a therapeutic peripheral procedure, during pullback, the manufacturer's catheter's tip broke in two pieces, but remained intact to the non-manufacturer's's guidewire.The catheter and guidewire were removed as a unit and a new manufacturer's catheter was used to complete the procedure.The patient was discharged in normal condition.This product problem is being submitted because the tip broke in two pieces.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Blocks d9 & h3: the pioneer plus catheter was returned for evaluation.Block h3: the pioneer plus catheter was visually and microscopically inspected.Per the reported complaint, the catheter tip broke in two pieces.However, there was no separation observed at the distal tip, rather a portion of the polyamide separated from inside the catheter shaft.Measurements of the entire polyamide material concluded all portions were accounted for.Block h6: the probable cause is damage in use.Device manipulation, impact and applied pressure associated with use and handling can further affect the integrity of the device.Block h6 (component code correction): initial mdr listed code 3123 (tip).However, code 4721 (rod/shaft) is more appropriate based on the returned device evaluation.

• 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: 12677360
• Report Number: 3008363989-2021-00017
• Device Sequence Number: 1208114
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(17)221031(10)5041118
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: 10/25/2021
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/16/2021
• 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: COOK: 0.014" HYDRO ST GUIDE WIRE; COOK: 6F ANSEL INTRODUCER SHEATH
• Patient Age: 67 YR
• Patient Sex: Female