MAUDE Adverse Event Report: SPECTRANETICS CORPORATION BRIDGE OCCLUSION BALLOON; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	590-001
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4) patient weight - not available from facility.H3) the bridge device was returned to the manufacturer for evaluation.Visual inspection confirmed a tear in the balloon.The balloon burst circumstantially and lengthwise, displaying a uniform tear pattern without signs of external puncture or scratches.H6) based on the complaint details and evaluation, the probable cause for the balloon rupture may be due to patient anatomy (calcium in the vessel); however, the cause could not be established.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to cied system/pocket infection.Prior to the procedure, a spectranetics bridge occluding balloon was prophylactically inflated to ensure superior vena cava (svc) occlusion in the event that an emergency occurred.The bridge was placed on the guide wire and advanced to the svc.The balloon was inflated using a 60 cc syringe filled with contrast mixture.During deflation, blood was noticed in the syringe, so it was removed from the patient.Upon removal, a hole was noted near the base of the balloon; physician suspected it may have been torn by the calcium in the vessel.A new bridge device was staged, and the procedure was completed successfully with no reported patient harm.This report captures the bridge occlusion balloon (rescue balloon) that ruptured during staging, potential for harm with recurrence.

• Brand Name: BRIDGE OCCLUSION BALLOON
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 21437683
• Report Number: 3007284006-2025-00036
• Device Sequence Number: 11903991
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: (01)00813132024840(17)261113(10)0303338748
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

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: 590-001
• Device Catalogue Number: 590-001
• Device Lot Number: 0303338748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MERIT MEDICAL SYSTEMS BRIDGE PREP KIT.; ST. JUDE MEDICAL 188TC/46 RA PACING LEAD.; ST. JUDE MEDICAL 2088TC/58 RV PACING LEAD.
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American