MAUDE Adverse Event Report: BALT EXTRUSION MAGIC INFUSION CATHETER

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.

• 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 Key: 15852303
• MDR Text Key: 304203446
• Report Number: 3014162263-2022-00036
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 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 Number: MAGIC1,2FM
• Device Lot Number: 00493425
• 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 Received: 11/23/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other