MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number 105-5056

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Respiratory Insufficiency (4462)

Event Date 09/04/2020

Event Type  Injury  

Event Description

Abruzzo, t., abraham, k., karani, k.B., geller, j.I., vadivelu, s., racadio, j.M., zhang, b., <(>&<)> correa, z.M.(2021).Correlation of technical and adjunctive factors with quantitative tumor reduction in children undergoing selective ophthalmic artery infusion chemotherapy for retinoblastoma.Ajnr - american journal of neuroradiology, 42(2), 354¿361.Https://doi.Org/10.3174/ajnr.A6905.Medtronic review of the literature article found that 40 eyes of 35 pediatric patient were treated for retinoblastoma selective ophthalmic artery infusion chemotherapy (soaic).A 1.5f marathon microcatheter was the preferred catheter used in the procedures though it was noted a slightly smaller non-medtronic microcatheter was used in some cases if catheterization with the marathon could not be achieved.However, it was not specified which cases used the non-medtronic catheter.Serious adverse events reported in article included: 2 instances of hypotension in infants receiving intra-arterial verapamil (iav).Both required treatment with blood products.1 patient was also treated with calcium gluconate to counteract verapamil.In 1 case, post extubation laryngospasm required reintubation.Medical safety assessed that this event was not related to the marathon microcatheter but was a procedure-related event.

Manufacturer Narrative

Reported patient age (19 months) is representative of the average age from all patients included in the study.Reported patient sex (female) is representative of the majority of patients (12/20) included in the study.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MARATHON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15086371
• MDR Text Key: 296411352
• Report Number: 2029214-2022-01220
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: UNKONWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/22/2022
• 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
• Patient Age: 19 MO
• Patient Sex: Female