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	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2) patient date of birth - not available from facility.H3/h6) the bridge device was not returned for evaluation, thus no returned product investigation was performed.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 right atrial (ra) leads due to bacteremia.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.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, deflated, and staged in the inferior vena cava (ivc).Beginning with a spectranetics 16f glidelight laser sheath, and switching between the ra and rv lead, there was very little advancement; therefore, the decision was made to snare the leads from below.The bridge was removed; however, upon removal, a tear was noted.A new sheath was inserted, and a new bridge was staged, and the leads were removed successfully via snare, with no reported patient harm.This report captures the bridge occlusion balloon (rescue balloon) that ruptured, potential for harm with recurrence.
Additional Manufacturer Narrative
H3) the bridge device was returned to the manufacturer for evaluation.Visual inspection confirmed a tear in the balloon, approximately 20 mm from the distal balloon fuse.Using a scanning electron microscope (sem), jagged edges were observed on the balloon that suggest a puncture or snag, that matches both proximal and distal sides.A uniform repeating tear pattern was present along both cut edges on either side of the rough point, which suggests that the balloon continued to tear from being pulled.H6) based on the complaint details and evaluation, the probable cause for the balloon rupture is likely due to patient condition.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.

• 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: 21936273
• Report Number: 3007284006-2025-00088
• Device Sequence Number: 7893104
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: (01)00813132024840(17)261216(10)0303365522
• 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,Followup
• Report Date (Section B): 05/23/2025

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: 0303365522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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: SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES.; ST. JUDE MEDICAL 1888 RA PACING LEAD.; ST. JUDE MEDICAL 7121 RV ICD LEAD.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White