MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC IMPRESS BRAIDED INTRAVASCULAR BERENSTEIN CATHETER; DIAGNOSTIC CATHETER

Catalog Number 56535BER

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation.A follow up will be submitted when evaluation is complete.

Event Description

The account reports that during a peripheral procedure when removing the catheter from the patient, the physician noticed that the catheter tip had separated.The physician was able to see the catheter tip still on the wire under fluoroscopy.The wire and catheter tip were gently removed from the patient's left femoral artery still attached to the wire.A new catheter was used to finish the procedure.No patient injury or adverse event to report.

Manufacturer Narrative

One device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.A review of the device history and complaint data base could not be reviewed since the lot number was not provided.

• Brand Name: IMPRESS BRAIDED INTRAVASCULAR BERENSTEIN CATHETER
• Type of Device: DIAGNOSTIC 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: casey hughes ms, cqe ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6153452
• MDR Text Key: 61713782
• Report Number: 3010665433-2016-00068
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 56535BER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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