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

Model Number	FG-006917
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on(b)(6)2026.It was reported that the balloon leaked.A 6.0x60 145cm seismiq device was selected for use in an intravascular lithotripsy (ivl) procedure.During the procedure, a balloon leak was identified.The procedure was completed with the same device.There were no patient complications as a result of this event and the patient fully recovered.However, device analysis revealed a balloon tear/rupture along with a device fragment.
Additional Manufacturer Narrative
Media: media was returned in the form of a photo.Review of the media showed only the packaging of the device with no relevant information pertaining to the investigation.Device technical analysis: the returned product received by boston scientific consisted of a seismiq atk catheter.Visual examination revealed multiple shaft kinks.A balloon leak test was performed, and a longitudinal balloon tear/rupture and scratches were observed.Microscopic examination revealed polyimide damage and a polyimide fragment lodged inside the rupture.Device history records (dhr) review: the device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a review of the seismiq atk catheter device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was adverse event related to procedure.

• 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: 50857639
• Report Number: 2124215-2026-50482
• Device Sequence Number: 21338568
• Product Code: PPN
• UDI-Device Identifier: 00850056723053
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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 Expiration Date: 05/24/2026
• Device Model Number: FG-006917
• Device Catalogue Number: FG-006917
• Device Lot Number: 0000110076
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2025
• 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