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

Catalog Number	ASAPLP/C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during an emergent stemi aspiration procedure, the interventional guidewire [.014] was getting caught at the rapid exchange portion of an aspiration catheter.The guidewire was getting shredded [damaged] and fragmented/detached within the patient.An additional foreign body retrieval procedure was necessary to successfully retrieve the detached pieces from this patient.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The device was examined visually.The complaint is 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.

• Brand Name: ASAP ASPIRATION CATHETER
• Common Device Name: EMBOLECTOMY / THROMBECTOMY CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11023383
• Report Number: 1721504-2020-00108
• Device Sequence Number: 13670424
• Product Code: DXE
• UDI-Device Identifier: 00884450329306
• UDI-Public: 884450329306
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K132155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 09/28/2023
• Device Catalogue Number: ASAPLP/C
• Device Lot Number: H1941370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 03/24/2021
• 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: PT CHOICE GUIDEWIRE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention