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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 MAGIC1,2F
Device Problem Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 10/19/2015
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: "according to the first descriptive elements of the incident provided by the healthcare establishment and in the absence of product for expertise, the magic microcatheter (reference magic1.2fm, lot 00259519) would have burst following an overpressure during the glue injection.To avoid this phenomenon of bursting due to overpressure, it is indicated on the product label to use a syringe of at least 2.5 ml.An investigation into the batch file was carried out and did not reveal any anomalies.The controls at 100% were compliant during the manufacture of this batch, including a pressure control at 7 bars also compliant.Likewise, the interrogation of our complaints / materiovigilance database does not identify any similar or other incident on this batch of magic 00259519.The pressure resistance test (7 bars) n ¿ 33 indicated in step n ¿ 25 of the manufacturing sheet does not detect any defect for the entire batch n ¿ 259519.The manometers used for this control are monitored in metrology.No significant deviation that could invalidate the validity of the results was observed during their monitoring.Calibration certificates are available.The tensile tests carried out in extrusion on the pursil white, pursil turquoise and pursil pink tubes used for this batch comply with the specifications of the iso 10555-1 standard and of the instruction pd-it-74 rev.B.Review of the batch file indicates that all quality criteria have been met and that the product meets specifications.No causal link between the quality of the product and the nature of the above incident can be established.".
 
Event Description
It was reported that: "during the operation consisting in embolizing a malformed cerebral artery, when injecting the 50% glubran glue mixture (ref.Gnb2 - lot 306021614) and lipiodol (lot 14lu605a), the operator notes that the sticks towards the end of the microcatheter due to a spontaneous leak by injection at the level of the intermediate part of the catheter (leak not visualized during the previous screen printing).The operator did not apply force during the injection and did not feel any resistance.In accordance with the recommendations, the syringe used had a capacity greater than 2ml, the mixture poured out at the level of the basilar trunk.Leak well visualized when withdrawing the catheter.Associated materials: hybrid 007d and 007j microguide (balt) introducer ksaw603890rbshtlflexhc (cook); associated equipment compatible with the manufacturer's recommendations.Removal of the device and the affected lot from the microcatheter.".
 
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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 Key11448936
MDR Text Key244176421
Report Number3014162263-2021-00009
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K023351
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
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 Date09/01/2020
Device Model NumberMAGIC1,2F
Device Lot Number00259519
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/23/2015
Initial Date FDA Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2015
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) Hospitalization; Life Threatening;
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