MAUDE Adverse Event Report: BALT EXTRUSION MAGIC INFUSION CATHETER

Model Number MAGIC1,2F

Device Problem Material Rupture (1546)

Patient Problem Muscle Weakness (1967)

Event Date 08/18/2022

Event Type  Injury  

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: "description of the incident given to me by the doctor (i was not present during the intervention): patient with avm already treated several times since years.General: use of a 1.2f magic catheter with 007d hybrid guide and 3ml syringes.Injection of glucose before injection of a 50/50 glubran and lipiodiol mix.Navigation in the left posterior circulation, selective injection of the contrast liquid to see the parts of the nidus that he wanted to select, followed by injection of a glucose solution then he wanted to re-check the correct position of the catheter and again injected contrast, after confirming the correct position in the area to be embolized, another injection of glucose solution followed by the injection of a 50/50 glubran glue/lipiodiol mix.During the injection during the first seconds the glubran / lipiodiol mix came out of the catheter distally (where it should) he saw it come out in the area to be embolized then as it was good, decision to continue injecting and at that moment he did not more seen fluid exit distally from the catheter tip and seen fluid exit more proximally from the catheter along the catheter in an undesired area.The doctor immediately stopped the injection, removed the magic and carried out checks which confirmed that the glubra/lipiodiol mix was present in unwanted areas, in particular the basilar trunk.To try to limit the effects, thrombo-aspiration was performed using a sofia 5f catheter in the basilar trunk.In addition, an anti-platelet treatment (agrastat) was injected.The patient woke up and upon awakening the patient presented with hemiparesis".

Event Description

It was reported that: "description of the incident given to me by the doctor (i was not present during the intervention): patient with avm already treated several times since years.General: use of a 1.2f magic catheter with 007d hybrid guide and 3ml syringes.Injection of glucose before injection of a 50/50 glubran and lipiodiol mix.Navigation in the left posterior circulation, selective injection of the contrast liquid to see the parts of the nidus that he wanted to select, followed by injection of a glucose solution then he wanted to re-check the correct position of the catheter and again injected contrast, after confirming the correct position in the area to be embolized, another injection of glucose solution followed by the injection of a 50/50 glubran glue/lipiodiol mix.During the injection during the first seconds the glubran / lipiodiol mix came out of the catheter distally (where it should) he saw it come out in the area to be embolized then as it was good, decision to continue injecting and at that moment he did not more seen fluid exit distally from the catheter tip and seen fluid exit more proximally from the catheter along the catheter in an undesired area.The doctor immediately stopped the injection, removed the magic and carried out checks which confirmed that the glubra/lipiodiol mix was present in unwanted areas, in particular the basilar trunk.To try to limit the effects, thrombo-aspiration was performed using a sofia 5f catheter in the basilar trunk.In addition, an anti-platelet treatment (agrastat) was injected.The patient woke up and upon awakening the patient presented with hemiparesis" 11oct2022, additional information by be - "unfortunately, the last information that we had is that the patient has hemiparesis.".

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 investigation was completed 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 two (2) ruptures with a "bubble" shape on the microcatheter distal extremity (white pursil) despite of the incident description mentioned only one leakage.The rupture nearest the reduction of the tube (before the turquoise pursil) presents a stronger deformation of the tube and seems to be the first rupture.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 homogenous and there was not any foreign matter (e.G.Fibers) which could have occluded the magic's lumen.Only blood trace appears around the more distal rupture but that seems to be post rupture since the longitudinal cut showed that there is no blood in the distal tip of the catheter after the rupture.This configuration of rupture sites 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, with contrast liquid in the patient and glycolic solution before injection of glue as described in the instructions for use and the incident description: no leakage was noticed at this stage according to 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.Comprehensive analysis of this failure mode will remain subject to continued tracking for any unacceptable increase in trend as part of our post-marketing surveillance program.At this time, no such increase has been observed.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.

• 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: 15438677
• MDR Text Key: 300067019
• Report Number: 3014162263-2022-00028
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K023351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MAGIC1,2F
• Device Lot Number: 00490027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• 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): Required Intervention; Other