MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS®.BRAIDED H1 CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	412535HH1
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Codes	Ischemia (1942); Foreign Body In Patient (2687)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for an evaluation.A supplemental report will be submitted once the evaluation has been completed.A review of the manufacturing history record is in progress.
Event or Problem Description
The account alleges that an elderly male patient presented with an ischemic stroke and was brought in for a mechanical thrombectomy.The physician used a merit 4f h1 diagnostic catheter with a terumo guide wire for this procedure.As soon as the diagnostic catheter was advanced over the terumo guidewire via the right femoral artery, the diagnostic catheter detached into two pieces.This was verified under fluoroscopy.The physician used a vascular snare device to retrieve one foreign body from the patient.The other foreign body migrated into the patient's anterior tib artery.The patient will require the surgical removal of the remaining foreign body.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.However, photographs of the defect were provided.Based on the photos, the complaint is confirmed.Root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were identified.

• Brand Name: IMPRESS®.BRAIDED H1 CATHETER
• 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: 20511117
• Report Number: 3010665433-2024-00041
• Device Sequence Number: 7044587
• Product Code: DQO
• UDI-Device Identifier: 00884450683842
• UDI-Public: 884450683842
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 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: 02/17/2025
• Device Catalogue Number: 412535HH1
• Device Lot Number: E2354703
• 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: 11/06/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• 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: TERUMO GUIDEWIRE.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Male