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

Catalog Number PPLUS120

Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  Injury  

Event Description

Pioneer catheter disfunction which caused us to end the case.The wire coiled during removal and was stuck inside the catheter.No harm was done to the patient.Fda safety report id # (b)(4).

• Brand Name: PIONEER PLUS CATHETER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): VOLCANO CORPORATION; rancho cordova CA 95670
• MDR Report Key: 11744479
• MDR Text Key: 248171116
• Report Number: MW5101060
• Device Sequence Number: 1
• Product Code: ITX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: PPLUS120
• Device Lot Number: 4970246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 74