MAUDE Adverse Event Report: VOLCANO CORPORATION PIONEER PLUS CATHETER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number PPLUS120

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem Occlusion (1984)

Event Date 11/03/2020

Event Type  malfunction  

Event Description

The right external iliac artery was occluded, and a wire would not pass.The md was planning to put a stent into that artery.Because the wire would not pass, per the op note, "this necessitated the use of a pioneer reentry device with an 0.014 wire and chromaflo guided intravascular ultrasound with a reinjury system and gaining access into the common iliac artery and ultimately into the level of the aorta." the second surgeon in the case described it like this: "we attempted to cross the lesion within the true lumen; however, the plaque was significant within the external iliac artery.We used a pioneer reentry device with a 0.014 wire and chromaflo to orient the reentry device towards the arterial aspect.This was reentered just distal to the hypogastric artery.We were able to place a 0.014 wire up to the level of the aorta." during a stenting procedure to the right external iliac artery of a patient with profound atherosclerotic disease with bilateral lower extremity disabling claudication secondary to severe aortoiliac and bilateral iliofemoral atherosclerotic disease, a guide wire became lodged, in the pioneer plus dual-guidewire catheter (wire got stuck in the pioneer plus catheter)and broke.Both the wire and pioneer plus dual-guidewire catheter had to be removed from the patient and a new device and wire were opened to complete the procedure.Patient recovered without any issues.A representative from volcano (manufacturer) now has possession of the device.

• Brand Name: PIONEER PLUS CATHETER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 10918799
• MDR Text Key: 218673104
• Report Number: 10918799
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PPLUS120
• Device Catalogue Number: PPLUS120
• Device Lot Number: 4923956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 91