MAUDE Adverse Event Report: Bolt Medical, Inc. SEISMIQ; Percutaneous Catheter, Ultrasound

Model Number	FG-006919
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury

• Brand Name: SEISMIQ
• Common Device Name: Percutaneous Catheter, Ultrasound
• Manufacturer (Section D): Bolt Medical, Inc.; 2131 faraday ave; carlsbad CA 92008
• Manufacturer (Section G): Bolt Medical, Inc.; 2131 faraday ave.; carlsbad CA 92008
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50796945
• Report Number: 2124215-2026-49574
• Device Sequence Number: 10515498
• Product Code: PPN
• UDI-Device Identifier: 00850056723077
• UDI-Public: (01)00850056723077(17)270417(10)112319
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K250225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2026

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 Model Number: FG-006919
• Device Catalogue Number: FG-006919
• Device Lot Number: 0000112319
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Supplement Date Received by Manufacturer: 09/21/2026; 09/25/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/25/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female