MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS®.BRAIDED CATHETER; INTRAVASCULAR, DIAGNOSTIC CATHETER

Catalog Number 512535HH1

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

Patient Problems Stroke/CVA (1770); Foreign Body In Patient (2687)

Event Date 10/28/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device will not be returning for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.

Event Description

The account alleges that during a cerebral thrombectomy procedure to remove clot from an artery in a patient actively experiencing a cerebral vascular stroke (cvs), the catheter tip detached near the patient's aorta.The physician attempted to externalized the foreign body with a vascular snare device when the foreign body fragmented in to six additional pieces.No fragments migrated into the cerebral vasculature system.All fragments were located within the patient's aorta.The physician attempted to treat the patient stroke medically because all operators were engaged in retrieval of the fragments for more than 4 hours.The physician was unable to complete the thrombectomy procedure resulting in a cerebral infarction for the patient.Patient was placed on a ventilator as operators were not able to perform thrombectomy successfully.

Manufacturer Narrative

The suspect medical device was not returned for investigation.The complaint could not be 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.Should the device be returned later, the investigation will be reopened.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Type of Device: INTRAVASCULAR, DIAGNOSTIC CATHETER
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15764789
• MDR Text Key: 303394782
• Report Number: 3010665433-2022-00122
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450032534
• UDI-Public: 884450032534
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2022
• Device Catalogue Number: 512535HH1
• Device Lot Number: E1752818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2022
• 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: INTERVENTIONAL GUIDEWIRE
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Hospitalization