MAUDE Adverse Event Report: BALT USA MAGIC FLOW-DEPENDANT MICROCATHETER

Model Number	MAGIC1,5F
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the physician was using magic in a ruptured avm.Magic was placed in appropriate vessel.Angio was performed.Started to deliver glue nbca.They saw glue come out of the middle of the catheter and travel distal.Happened all of a sudden.They removed the catheter and continued the treatment with another catheter.It is hard to know if there was any patient injury to ruptured catheter.The avm was ruptured before hand.Patient was really sick.He was using a 3cc syringe for injections." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference # (b)(4).Conclusion of investigation pending analysis from supplier, balt extrusion.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.
Event or Problem Description
It was reported that: "the physician was using magic in a ruptured avm.Magic was placed in appropriate vessel.Angio was performed.Started to deliver glue nbca.They saw glue come out of the middle of the catheter and travel distal.Happened all of a sudden.They removed the catheter and continued the treatment with another catheter.It is hard to know if there was any patient injury to ruptured catheter.The avm was ruptured before hand.Patient was really sick.He was using a 3cc syringe for injections." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference (b)(4).Conclusion of investigation pending analysis from supplier, balt extrusion.The product analysis was completed by supplier balt extrusion.Summary as follows: the returned device (magic1,5f) has been inspected in our quality laboratory.During our analysis we noticed the following points: the operator observed a rupture with a "bubble" shape on the microcatheter distal extremity (white pursil).The rupture is approximatively at 187mm from the distal part.This configuration of rupture site with a tubing inflation and dilation is typical of an overpressure.The lhrs (lot history records) review did not highlight any anomaly which could potentially explain the issue experienced during the procedure.During the manufacturing process, several tests are performed: integrity of the tubes is 100% controlled by visual inspection.Smooth navigation of a gauge through the microcatheter over the entire length is 100% controlled.All catheters are 100% controlled with a leakage/pressure test and 2 samplings are tested till bursting as destructive test.No other complaint is registered on this batch number to date in our database.No other complaint is registered on this batch number to date in our database.Based on data from our post marketing surveillance experience and the product investigation results, these kinds of catheters ruptures (i.E.With a tube dilation) are generally explained by an overpressure above the maximum 7-bars limit as per indicated on the label and in the instructions for use.This overpressure could be explained by a too strong injection in the microcatheter magic.As mentioned on the label the catheter shall not be infused with a syringe smaller than 2,5 ml (piston diameter smaller than 10 mm).However, the issuer indicated that he was used a 3cc syringe for injection.One the other hands, kinks and flattened areas of the catheter can also have an impact on the pressure felt during injection, leading to overpressure but we didn't observe any kink on the catheter during his investigation.In conclusion we lack information to conclude on the precise root cause of the incident encountered.However, the most probable hypothesis could be related to the pressure applied during the injection in the catheter.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 FLOW-DEPENDANT MICROCATHETER
• Common Device Name: MAGIC
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 20314139
• Report Number: 3014162263-2024-00078
• Device Sequence Number: 20857820
• Product Code: KRA
• UDI-Device Identifier: 00818053022838
• UDI-Public: (01)00818053022838(11)191209(17)241128(10)00383258
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K213435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: 11/28/2024
• Device Model Number: MAGIC1,5F
• Device Lot Number: 00383258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown