MAUDE Adverse Event Report: BOLT MEDICAL, INC. SEISMIQ; PERCUTANEOUS CATHETER, ULTRASOUND

Model Number	FG-006915
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst and became difficult to remove.A seismiq atk catheter was selected for use in a pad (peripheral artery disease) procedure.During the procedure, the balloon burst and became difficult to remove.The whole system was taken out with the wire.

• 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 ; 7634941632
• MDR Report Key: 25107654
• Report Number: 2124215-2026-24688
• Device Sequence Number: 13084506
• Product Code: PPN
• UDI-Device Identifier: 00850056723039
• UDI-Public: (01)00850056723039
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K250225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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-006915
• Device Catalogue Number: FG-006915
• Device Lot Number: 0000110961
• 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: 04/09/2026
• Initial Report FDA Received Date: 05/06/2026
• Date Device Manufactured: 01/21/2026
• 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