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

Model Number	FG-006917
Medical Device Problem Codes	Nonstandard Device (1420); Connection Problem (2900); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter did not display inflation pressure on the console despite the balloon being inflated.A seismiq ivl catheter was selected for use to treat an 80% stenosed lesion with severe concentric calcification and mild vessel tortuosity it was reported that, after the balloon was deflated using the inflator and subsequently reinflated to 4.0 atmospheres, the pressure did not register on the console screen; however, the inflator indicated 4.0 atmospheres, and the balloon was observed to be inflated.An alert message stating "remove and reinsert catheter connector" was displayed on the console.Troubleshooting was attempted by unplugging and reinserting the catheter and by deflating and reinflating the balloon; however, the issue was not resolved.The device was exchanged, and the procedure was completed without patient complications.

• 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: 25847626
• Report Number: 2124215-2026-38340
• Device Sequence Number: 18750688
• Product Code: PPN
• UDI-Device Identifier: 00850056723053
• UDI-Public: (01)00850056723053(17)270304(10)111178
• 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
• Report Date (Section B): 09/14/2026

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-006917
• Device Catalogue Number: FG-006917
• Device Lot Number: 0000111178
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2026
• 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
• Patient Sex: Unknown