MAUDE Adverse Event Report: BALT EXTRUSION MAGIC INFUSION CATHETER

Model Number MAGIC1,5FMP

Device Problem Fluid/Blood Leak (1250)

Patient Problem Brain Injury (2219)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

Balt usa has aligned the united states mandatory reporting process with balt extrusion.Under this improved reporting process, "similar devices" between balt extrusion and balt usa have been defined.All complaints received by balt extrusion and related to such similar devices which are marketed in the united states by balt usa shall be evaluated by balt usa according to mdr requirements.A retroactive analysis was performed on legacy complaint records to identify any prior occurrences deemed mdr reportable.This complaint has been deemed mdr reportable under this program and recorded in the balt usa complaint management system.Balt usa's reference number: (b)(4).Here is the summary of event and investigation as reported by balt extrusion: "the returned device was inspected in our laboratory.We confirm that the microcatheter was ruptured on the pursil supple white portion.This overpressure results of the fact that the physician used a 1cc syringe during injection.As clearly indicated on the label and in the ifu, a syringe 2.5cc mini must be used with microcatheters magic.The procedure must be stopped and the catheter removed immediately, if any resistance occurs during the injection.The dhr (device history record) review did not highlight any anomalies during manufacturing.All units of this batch succeeded the pressure test (100% controlled).Furthermore, tensile tests on pursil white portion, performed during extrusion activities, conformed the specifications.In conclusion, no causal link between the product quality and the nature of the incident can be established." 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 Description

It was reported that: "the magic catheter ruptured at approx.12 cm from the tip during injecting nbca (12%) for tea of tentorial dural arteriovenous (davf).A 1cc syringe was used for injection.The guide wire was coviden mirage.2 magic catheters and one baltacci catheter were used and then the incident occurred with 4 th catheter, magic.The doctor was slowly infusing nbca with the 1 cc syringe while confirming that the nbca was coming out from the tip of the catheter when the ruptured occurred.The catheter was removed immediately from the patient and the unintended embolic material at basilar artery was removed with penumbra system and solitaire, however, residual nbca remained at peripheral vessel.The doctor knows that magic catheter must not be used with 1 cc syringe.We only received photos of the catheter.The hospital request balt's opinion from the photos, the rate of rupture cases and the rate of other incident cases besides ruptured catheter balt have received.".

• Brand Name: MAGIC INFUSION CATHETER
• Type of Device: MAGIC
• Manufacturer (Section D): BALT EXTRUSION; 10 reu de la croix vigneron; montmorency, 95160 ; FR 95160
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 11389139
• MDR Text Key: 241929778
• Report Number: 3014162263-2021-00008
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/25/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Model Number: MAGIC1,5FMP
• Device Lot Number: 00255173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• 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
• Patient Outcome(s): Hospitalization; Life Threatening