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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 Problems Burst Container or Vessel (1074); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2022
Event Type  malfunction  
Manufacturer Narrative
Balt usa reference #(b)(4).This reported complaint concerns a balt extrusion device.As legal manufacturer, balt extrusion is responsible for all post-market activities including the investigation, root cause, and customer follow-up related to this complaint.Balt usa commercializes a similar device in the us market which is also manufactured by balt extrusion, and has initiated this complaint for the sole purposes of evaluation for potential reportability under united states mdr requirements.Investigation pending analysis results from legal manufacturer 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 Description
It was reported that: "rupture of the catheter 3cm proximal to the tip after uncomplicated probing and 1st injection." 31oct2022, additional information provided by issuer: "it is mentioned that the catheter "ruptured".Does this mean the tip of the microcatheter broke off from the rest of the microcatheter? if so, how was the tip retrieved from the patient? the catheter looked like it had burst open at one point, this can be seen very well on the device that was sent back.It is indicated in the form that no patient injury was sustained.Were any other adverse events that occurred with the patient as a result of the failure? thank you for your help.No.".
 
Event Description
It was reported that: "rupture of the catheter 3cm proximal to the tip after uncomplicated probing and 1st injection." 31oct2022, additional information provided by issuer - "it is mentioned that the catheter "ruptured".Does this mean the tip of the microcatheter broke off from the rest of the microcatheter? if so, how was the tip retrieved from the patient? the catheter looked like it had burst open at one point, this can be seen very well on the device that was sent back it is indicated in the form that no patient injury was sustained.Were any other adverse events that occurred with the patient as a result of the failure? thank you for your help.No.".
 
Manufacturer Narrative
Balt usa reference #(b)(4).This reported complaint concerns a balt extrusion device.As legal manufacturer, balt extrusion is responsible for all post-market activities including the investigation, root cause, and customer follow-up related to this complaint.Balt usa commercializes a similar device in the us market which is also manufactured by balt extrusion, and has initiated this complaint for the sole purposes of evaluation for potential reportability under united states mdr requirements.The device investigation was performed by legal manufacturer balt extrusion.Summary as follows: the returned device was inspected in our quality department with the support of the engineering teams.During our analysis we noted that only magic catheter had been returned.We observed the magic under binocular and we identified one (1) rupture with a "bubble" shape at 7.5cm of the microcatheter distal extremity (on white pursil).Then, we checked the internal lumen of the microcatheter performing a longitudinal cut, but we did not notice any abnormality.The internal walls tube was homogeneous and there was not any foreign matter (e.G.Fibers) which could have occluded the magic's lumen.This configuration of rupture site with a tubing inflation and dilation is typical of an overpressure.The review of the lot history records (lhrs) for this specific magic batch did not highlight any anomaly that could potentially explain the issue experienced during the procedure.During the manufacturing process, following tests are performed: - integrity of the tubes is 100% controlled by visual inspection.- smooth navigation of a gauge (0.20mm) 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 (superior to 10bars).No other complaint is registered on this batch number to date in our database.In addition, the pressure resistance of the microcatheter magic is validated and this validation demonstrated that the devices cannot burst on the pressure range allowed as per indicated on the label and in the ifu.By definition, internal lumen of the microcatheter was purged with saline during preparation as described in the instructions for use: no leakage was notified at this stage by the issuer.Based on the observations made during the analysis and the data issued from our post-marketing surveillance program: 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 and in the ifu mde0001 (§ 6) "the using pressure must not exceed the maximum value of 7 bars/100 psi as indicated on the label.Do not infuse with a syringe smaller than 2,5 ml (piston diameter smaller than 10 mm).The procedure must be stopped and the microcatheter removed immediately if any resistance occurs during the injection".In conclusion, we lack information to accurately determine the origin of the reported event even if the quality of the device does not seem to be involved.The most probable cause could be an overpressure above the maximum limit allowed.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.
 
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Brand Name
MAGIC INFUSION CATHETER
Type of Device
MAGIC
Manufacturer (Section D)
BALT EXTRUSION
10 rue de la croix vigneron
montmorency, 95160
FR  95160
Manufacturer (Section G)
BALT EXTRUSION
10 rue de la croix vigneron
montmorency, 95160
FR   95160
Manufacturer Contact
moises colin
29 parker
irvine, CA 92618
9497881443
MDR Report Key15852303
MDR Text Key304203446
Report Number3014162263-2022-00036
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K023351
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/06/2023
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
Device Operator Health Professional
Device Model NumberMAGIC1,2FM
Device Lot Number00493425
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2022
Initial Date FDA Received11/23/2022
Supplement Dates Manufacturer Received10/27/2022
Supplement Dates FDA Received01/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2022
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) Other;
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