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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BALT EXTRUSION MAGIC INFUSION CATHETER

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BALT EXTRUSION MAGIC INFUSION CATHETER Back to Search Results
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.".
 
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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 Key11398867
MDR Text Key234250896
Report Number3014162263-2021-00010
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K023351
Number of Events Reported1
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 Date07/01/2015
Device Model NumberMAGIC1,2FM
Device Lot Number00215946
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/22/2015
Initial Date FDA Received03/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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