MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS®.BRAIDED.CATHETER SIMMONS 1; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	510038SIM1/CN
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that during the procedure the 5f sim 1 catheter tip fragmented during catheter manipulations.The foreign bodies were retrieved from the patient.There are no additional patient consequences to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed and a root cause could not be determined.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.CATHETER SIMMONS 1
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr,; pearland TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr,; pearland TX 77047
• Manufacturer Contact: bryson heaton rn ; 1600 merit parkway; south jordan, UT 84084 ; 8012531600
• MDR Report Key: 20465626
• Report Number: 3010665433-2024-00043
• Device Sequence Number: 7612873
• Product Code: DQO
• UDI-Device Identifier: 00884450009284
• UDI-Public: 00884450009284
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2024

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: 01/10/2025
• Device Catalogue Number: 510038SIM1/CN
• Device Lot Number: E2331986
• 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: 10/13/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTERVENTIONAL GUIDEWIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown