MAUDE Adverse Event Report: BALT EXTRUSION MAGIC INFUSION CATHETER

Model Number MAGIC1,2F

Device Problem Material Rupture (1546)

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

Event Date 07/21/2022

Event Type  malfunction  

Event Description

It was reported that: "during the treatment of an avm and navigation with magic 1.2f with hybrid 008 (hybrid008d lot 00435477) the physician realized that the distal part of the magic was perforated by the guidewire.Before introducing the magic 1.2f in the patient they prepare the magic, purge the id, i checked the magic and everything was ok." incident report form submitted for this complaint indicated no patient injury was sustained.

Manufacturer Narrative

Balt usa reference (b)(4).Note: this complaint file is being reported late as part of a corrective action following an fda inspection.After a review of historical complaint files, it was determined that for this compaint the claimed malfunction did not lead to a death or serious injury.However, based on post market surveillance data and the intial information that was reported to balt, the same malfunction has led to a serious injury or death in a separate incident which was already mdr reported (remains as an unlikely probability according to risk analysis document).Further analysis pending final investigation results from legal manufacture.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.

• Brand Name: MAGIC INFUSION CATHETER
• Type of Device: MAGIC
• Manufacturer (Section D): BALT EXTRUSION; 10 rue de la croix vigneron; montmorency, 95160 ; FR 95160
• Manufacturer (Section G): BALT EXTRUSION; 10 rue de la croix vigneron; montmorency, 95160 ; FR 95160
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 17573000
• MDR Text Key: 321693769
• Report Number: 3014162263-2023-00041
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 03700481337929
• UDI-Public: (01)03700481337929(11)220523(17)270428(10)00485822
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K023351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2023

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
• Device Operator: Health Professional
• Device Model Number: MAGIC1,2F
• Device Lot Number: 00485822
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1