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

Catalog Number	ASAP100/B
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	11/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is 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 an emergent percutaneous transluminal coronary angioplasty [ptca] stemi procedure, an interventional guidewire became stuck within the aspiration catheter.The physician had successfully acquired retrograde arterial access and had negotiated the patient's ascending aorta under fluoroscopy with the aspiration catheter.During aspiration catheter manipulations the interventional guidewire became stuck within the aspiration catheter.The physician was forced to remove all interventional equipment and make a second attempt in treating the patient.The patient tolerated the procedure well.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The product risk documentation was reviewed.The reported failure mode is included.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: 10825637
• Report Number: 1721504-2020-00092
• Device Sequence Number: 3680382
• Product Code: DXE
• UDI-Device Identifier: 00884450033005
• UDI-Public: 884450033005
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: 05/25/2023
• Device Catalogue Number: ASAP100/B
• Device Lot Number: H1838380
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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: ABBOT ASAHI SION GUIDEWIRE .014
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention