MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - MEXICO IMPRESS®.BRAIDED.4FCATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	46535RIM/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that a 4f catheter detached within the patient.The foreign body was retrieved from the patient.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A supplemental report will be submitted once the evaluation is complete.
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.The device was discarded at the account.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were identified.A search of the complaint database was performed and one similar complaint with this lot number was identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: IMPRESS®.BRAIDED.4FCATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - MEXICO; 8830 siempre viva rd #100; san diego CA 92104
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - MEXICO; 8830 siempre viva rd #100; san diego CA 92104
• Manufacturer Contact: bryson heaton r.n. ; 1600 merit pky; south jordan, UT 84095 ; 8012665654
• MDR Report Key: 20922298
• Report Number: 3011642792-2024-00091
• Device Sequence Number: 5042998
• Product Code: DQO
• UDI-Device Identifier: 00884450712184
• UDI-Public: 884450712184
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K053171
• 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
• Report Date (Section B): 11/29/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2024
• Device Catalogue Number: 46535RIM/B
• Device Lot Number: I2971973
• 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: 11/29/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown