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

Catalog Number	46538KA2-H
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device will not be returning for engineering evaluation.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that during an av fistulagram thrombectomy on (b)(6) 2023, the tip of the catheter detached within the patient's fistula.The surgeon used a vascular snare device to successfully externalize the foreign body liberating the fistula.The patient tolerated the procedure well, no additional consequences to report.
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.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 have been identified.Should the device be returned at a later date, the investigation will be reopened.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Common Device Name: 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: 16907340
• Report Number: 3010665433-2023-00036
• Device Sequence Number: 6837284
• Product Code: DQO
• UDI-Device Identifier: 00884450042564
• UDI-Public: 884450042564
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K093004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 46538KA2-H
• 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: 05/01/2023
• Supplement Date Received by Manufacturer: 06/18/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTERVENTIONAL GUIDEWIRE.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown