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

Model Number	00884450033005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during and emergent percutaneous cardiac intervention [pci], the aspiration catheter became entangled within the patient's rca.The physician had acquired retrograde, arterial vascular access and was attempting to aspirate targeted thrombus/clot identified within the patients right coronary artery [rca].The patient was hemodynamically unstable on and off throughout the procedure.The first aspiration pass was successful but, during the second aspirations pass the guidewire had exited the aspiration catheter and during catheter manipulations the guide wire, guide catheter and aspiration catheter became entangled.The physician removed all interventional equipment and had to open and introduce new equipment to successfully complete the procedure.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: ASAP ASPIRATION CATHETER
• Common Device Name: ASPIRATION CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 10403524
• Report Number: 1721504-2020-00060
• Device Sequence Number: 3066055
• Product Code: DXE
• UDI-Device Identifier: 00884450033005
• UDI-Public: 00884450033005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100569
• 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): 07/31/2020

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: 04/30/2022
• Device Model Number: 00884450033005
• Device Catalogue Number: ASAP100/B
• Device Lot Number: H1577285
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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: GUIDE CATHETER; GUIDE WIRE .014; GUIDE CATHETER; GUIDE WIRE .014
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Weight: 102