MAUDE Adverse Event Report: BALT EXTRUSION MAGIC INFUSION CATHETER

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.".

• 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: 11448936
• MDR Text Key: 244176421
• Report Number: 3014162263-2021-00009
• 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: 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 Date: 09/01/2020
• Device Model Number: MAGIC1,2F
• Device Lot Number: 00259519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening