MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MERIT MAESTRO MICROCATHETER

Model Number	00884450038468
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a left uterine fibroid embolization [ufe] procedure on (b)(6) 2020, the microcatheters radiopaque marker band detached within a patient.The physician had acquired right retrograde femoral artery access and had negotiated the patient's common iliac bifurcation with a guidewire and a 5f guide catheter.During microcatheter manipulations over the wire within the patient's left uterine artery the marker band detached.The physician noted the patient's anatomy was tortuous and very difficult to navigate.The radiopaque band became embedded within the patient's vasculature system that was feeding the fibroid.The decision was made to leave the foreign body acting as an embolic within the patient.The embolization procedure was successfully completed.The outpatient tolerated the procedure well and was discharged to home without further consequence.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to rough handling.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: MERIT MAESTRO MICROCATHETER
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan,, ut
• MDR Report Key: 10119506
• Report Number: 1721504-2020-00030
• Device Sequence Number: 2309709
• Product Code: KRA
• UDI-Device Identifier: 00884450038468
• UDI-Public: 00884450038468
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 00884450038468
• Device Catalogue Number: 29MC29130ST/D
• Device Lot Number: H1702725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDECATHETER-MHK 5F-MERIT.; GUIDEWIRE-TRUEFORM-MERIT.