MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PERFORMA BRAIDED CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	7718-B0/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a transjugular intrahepatic portosystemic shunt [tipss] procedure.The physician had acquired venous access via the internal jugular vein with a 10f sheath.During manipulations over a stiff guidewire under fluoroscopy, the catheter tip detached.The tip remained on the guide wire.The physician was able to remove both the detached catheter tip and guidewire together as one unit.No additional medical intervention was necessary.The event was not considered life-threatening by the attending physician.No permanent damage to body function or structure to report.A new catheter was used to complete the procedure for the patient.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional 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: PERFORMA BRAIDED CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16195344
• Report Number: 3011642792-2023-00004
• Device Sequence Number: 12278657
• Product Code: DQO
• UDI-Device Identifier: 00884450002919
• UDI-Public: 884450002919
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K943739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2025
• Device Catalogue Number: 7718-B0/B
• Device Lot Number: I2463631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown