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

Model Number	FG-010978
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the console would not turn on and there was error message to restart the console.As a result, the procedure was not completed, requiring additional surgery.The seismiq intravascular lithotripsy console was selected for use.During the procedure, the console would not turn on and there was error message to restart the console.Troubleshooting was performed but the issue was not resolved.As a result, the procedure was not completed and additional surgery was required.No impact on the patient was reported.No further information was provided to boston scientific.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product lot number is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.

• 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: 50150481
• Report Number: 2124215-2026-42085
• Device Sequence Number: 18792313
• Product Code: PPN
• UDI-Device Identifier: 00850056723084
• UDI-Public: (01)00850056723084
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 09/16/2026

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: 0000201501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 05/29/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown