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

Model Number	00884450437261
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
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 an emergent procedure, an interventional guidewire became stuck within the aspiration catheter formin a loop.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.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned at a later date, the investigation will be re-opened.

• Brand Name: ASAP
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 10897325
• Report Number: 1721504-2020-00098
• Device Sequence Number: 14069748
• Product Code: DXE
• UDI-Device Identifier: 00884450437261
• UDI-Public: 00884450437261
• 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): 11/13/2020

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 Model Number: 00884450437261
• Device Catalogue Number: ASAP100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening