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	08/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Patient information: no information available.Relevant tests: no information available.Suspect product(s): not applicable for this device.Implant and explant date: not applicable for this device.The pioneer plus catheter has not been returned for evaluation, thus no returned product investigation was performed.Recall number, correction/removal number: do not apply to this submission.
Event or Problem Description
It was reported that during a peripheral procedure, after multiple unsuccessful attempts to re-enter the true lumen, the physician removed the manufacturer's catheter from the patient.Upon removal, it was observed that the tip of the catheter separated within the non-manufacturer's sheath.The tip was removed along with the non-manufacturer's guidewire and sheath, and was not lost in the patient.The physician reinserted the sheath and guidewire to complete the procedure with a non-manufacturer's device.The patient was in stable condition and discharged as expected.This product problem is being submitted because the tip separated.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.The distal tip was detached and missing, the backing material and unibody were exposed; however, no rough/sharp edges were observed.Block h6: the probable cause of the reported failure is damage in use.Strain, impact, and forces associated with use can affect the integrity of the device.
Additional Manufacturer Narrative
Block e1: postal code (zip) updated to (b)(6).

• 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
• MDR Report Key: 12435989
• Report Number: 3008363989-2021-00010
• Device Sequence Number: 19727557
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(11)210429(17)230429(10)5122134
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2021

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: 04/29/2023
• Device Model Number: PPLUS120
• Device Catalogue Number: 400-0200.246
• Device Lot Number: 5122134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/09/2021; 09/27/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 09/22/2021; 09/27/2021
• 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: 0.014" THRUWAY GUIDE WIRE; COOK: 6F INTRODUCER SHEATH