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

Catalog Number 510038VER

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

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

Event Date 02/05/2024

Event Type  Injury  

Event Description

The account alleges that during an endo vascular aortic repair [evar] procedure, a catheter tip detached in the patient's descending abdominal aorta.Excessive force was not used during catheter manipulations.The foreign body was successfully externalized via balloon capture technique, liberating the vessel along with all residual interventional equipment.No additional patient consequences to report.

Manufacturer Narrative

The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.

Manufacturer Narrative

The suspect medical device has been returned for evaluation.The device was visually and microscopically investigated.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.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: IMPRESS®.BRAIDED CATHETER
• Type of Device: INTRAVASCULAR, DIAGNOSTIC CATHETER
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr,; pearland TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr,; pearland TX 77047
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18655608
• MDR Text Key: 334723847
• Report Number: 3010665433-2024-00003
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

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 Expiration Date: 02/11/2024
• Device Catalogue Number: 510038VER
• Device Lot Number: E2058224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• 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): Required Intervention