MAUDE Adverse Event Report: BALT EXTRUSION MAGIC INFUSION CATHETER

Model Number MAGIC1,2FM

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2013

Event Type  Death  

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: "at this stage of analysis: the microcatheter's rupture may be caused by an overpressure during glue injection.The overpressure may be a consequence of a catheter's occlusion and/or if the physician uses a syringe < 2.5 cc during injection.Indeed, as mentioned in the ifu and on the labelling (see above picture), a syringe 2.5cc mini should be used during injection.The procedure must be stopped and the catheter removed immediately, if any resistance occurs during the injection.The microcatheter's magic are 100% controlled during manufacturing with a 7 bar pressure test.The rate of complaints is between (b)(4).Main complaints are due to a device misuse.Since 2009, (b)(4) complaints subjected to vigilance (i.E.Declaration to competent authority).They are now closed except one which is still in progress ((b)(4) dated 2015, october 23th in (b)(6)).None highlighted an acknowledged defect of the medical devices at this date.No similar complaint reported on the batch 00215946.Device history record (dhr): the dhr review indicates that all microcatheters succeeded the 7 bar pressure test (step #22, control #29) except one which was rejected (i.E.194/195 = 99.5%).So, all marketed magic resisted at least a 7 bar pressure.".

Event Description

It was reported that: "the magic1.2 fm got ruptured during the procedure.Glue was used.Rupture occurred at the tip.".

• 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: 11398867
• MDR Text Key: 234250896
• Report Number: 3014162263-2021-00010
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K023351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2021

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: 07/01/2015
• Device Model Number: MAGIC1,2FM
• Device Lot Number: 00215946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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): Death