MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. ASAP ASPIRATION CATHETER; EMBOLECTOMY CATHETER

Model Number	00884450568385
Medical Device Problem Codes	Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	01/07/2023
Type of Reportable Event	Death
Event or Problem Description
The account alleges that during an emergent stemi aspiration atherectomy procedure attempt of the patient's posterolateral branch [plb] the aspiration catheter and asahi prowater guidewire could not be advanced into the targeted lower right coronary artery.The account alleges that during an emergent stemi aspiration atherectomy procedure, a asahi prowater guidewire was first advanced into the mid-right coronary artery [mrca].A merit asap catheter was then advanced over the asahi guidewire into the patient's mrca where the physician aspirated several times and successfully removed the targeted thrombus/clot from within the vessel.An additional angiographic image was taken and demonstrated that the patient had developed a new thrombus/clot within the plb during this procedure.The physician unsuccessfully attempted to reposition the merit aspiration [asap] catheter and guidewire into the patient's plb.Both the guidewire and aspiration catheter became stuck together during the vessel insertion attempt.Both devices were successfully removed together from the patient's vasculature as a unit.The physician states that the guidewire was severely bent/damaged after it was removed.No additional medical interventions were attempted.The patient expired in the recovery unit 18hrs later.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect medical device is expected to return for evaluation.A lot number has been provided and a review of the manufacturing history record is in progress.A follow-up report will be submitted once the evaluation is complete.A good faith effort of 3 or more attempts to collect additional information regarding this event has been successfully completed in a timely manner.No additional information about this event has been provided to the device manufacturer.
Event or Problem Description
The account alleges that an aspiration catheter detached within the patient's distal rca,/pda branch.The foreign body was not retrieved by the physician.No additional medications or surgical interventions necessary.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be re-opened.

• Brand Name: ASAP ASPIRATION CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16241984
• Report Number: 1721504-2023-00006
• Device Sequence Number: 6400822
• Product Code: QEZ
• UDI-Device Identifier: 00884450568385
• UDI-Public: 00884450568385
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K212199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2025
• Device Model Number: 00884450568385
• Device Catalogue Number: ASAP100/G
• Device Lot Number: H2467452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 01/27/2023; 05/05/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 02/01/2023; 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Sex: Unknown