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

Model Number 00884450555125

Device Problems Fracture (1260); Material Separation (1562)

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

Event Date 11/08/2022

Event Type  Injury  

Event Description

The account alleges that during use in an emergency surgery, approximately 20 centimeters of the exchange lumen broke off within the vessel of the patient.The physician removed with a capture device.No additional injury on patient.

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: ASAPLP¿
• Type of Device: CATHETER, EMBOLECTOMY
• 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: 15801614
• MDR Text Key: 303701659
• Report Number: 1721504-2022-00112
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00884450555125
• UDI-Public: 00884450555125
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K132155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

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: 00884450555125
• Device Catalogue Number: ASAPLP
• Device Lot Number: H2345108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention