MAUDE Adverse Event Report: BOLT MEDICAL, INC. SEISMIQ; Percutaneous Catheter, Ultrasound

Model Number	FG-010978
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction

• 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: 25898986
• Report Number: 2124215-2026-39437
• Device Sequence Number: 17627465
• Product Code: PPN
• UDI-Device Identifier: 00850056723084
• UDI-Public: (01)00850056723084(11)20260424
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K250225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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-010978
• Device Catalogue Number: FG-010978
• Device Lot Number: 0000201487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 04/24/2026
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown