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

Model Number	PPLUS120
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pioneer plus catheter was used in a peripheral therapeutic procedure to treat a cto in the proximal sfa.The catheter was loaded over a non-philips guidewire, and the guidewire went subintimal; however, the catheter was unable to completely cross the cto lesion.Attempts were made for reentry, but could not advance further; therefore ivus was performed in the right distal sfa.After a few unsuccessful attempts to enter the true lumen, the procedure was abandoned.During removal, the catheter got stuck, and the distal shaft separated inside the iliac artery, but remained intact to the guidewire.Attempts were made for removal; however, the catheter and the guidewire could not be pulled back into the 7 fr sheath, and blood loss was noted leading to anemia.The sheath was upsized to a 9 fr, and was able to be removed as a system.X-ray and angiography confirmed that no piece of the catheter was left inside the patient.The patient was discharged as expected.The physician believed that the cto likely caused or contributed to the catheter getting stuck on the guidewire, resulting in the separation.This adverse event and product problem is being submitted due to the distal shaft separation, requiring intervention (upsizing the sheath).
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block a5: no information available.Block c: not applicable for this device.Block d4: serial number not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the pioneer plus catheter was discarded and not returned for evaluation, thus no returned product investigation was performed.Block h6: based on the complaint details, the physician believed that the patient anatomy (cto) likely caused or contributed to the catheter separation.Blocks h7 & h9: do not apply to this submission.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.
Additional Manufacturer Narrative
Block d: brand name was updated from "pioneer plus pplus120" to "pioneer plus catheter" to match the product label.Catalog# was updated from "400-0200.246" to "pplus120".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.

• Brand Name: PIONEER PLUS CATHETER
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer Contact: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 17386288
• Report Number: 3008363989-2023-00032
• Device Sequence Number: 12362032
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(11)220322(17)240322(10)5341738
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 08/16/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: PPLUS120
• Device Catalogue Number: PPLUS120
• Device Lot Number: 5341738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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: ASAHI: 0.014" REGALIA GUIDEWIRE.; COOK: 7F FLEXOR INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 68 KG