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

Model Number 00884450437261

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  Injury  

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.

Event Description

The account alleges that during an aspiration procedure, the distal end of the aspiration catheter fractured within the patient.All foreign body objects were successfully removed from the patient.No additional consequences to report.

• Brand Name: ASAP ASPIRATION CATHETER
• Type of Device: 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 ; 8012084662
• MDR Report Key: 11373583
• MDR Text Key: 233329560
• Report Number: 1721504-2021-00011
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00884450437261
• UDI-Public: 00884450437261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450437261
• Device Catalogue Number: ASAP100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE .014
• Patient Outcome(s): Life Threatening; Required Intervention