MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS BRAIDED PERIPHERAL CATHETER

Catalog Number 410035VER

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

Patient Problem Foreign Body In Patient (2687)

Event Date 10/24/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The account alleges that post diagnostic peripheral vascular procedure, when the catheter was retrieved from the patient's vasculature the clinician noticed that the distal tip of the catheter was missing.The attending medical staff identified the missing tip under fluoroscopy, within the first perforating branch of the femoral artery.The account alleges that there was some vessel tortuosity, no calcification was identified.The physician used a vascular snare device to successfully externalize the foreign body from the patient liberating the vessel.The patient tolerated the procedure well.

Manufacturer Narrative

The suspect device was not returned for evaluation.However, a photograph of the device was received and examined.Evidence of elongation was observed, indicating the possibility of tortuous anatomy and external forces applied to the device.A review of the device history record was performed and no exception documents were identified.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: IMPRESS BRAIDED PERIPHERAL CATHETER
• Type of Device: PERIPHERAL 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: 18047550
• MDR Text Key: 327067849
• Report Number: 3010665433-2023-00091
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 410035VER
• Device Lot Number: E2614912
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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
• Patient Outcome(s): Required Intervention