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

Model Number	590-001
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A lead extraction procedure commenced to treat a patient.During prophylactic staging of a spectranetics bridge occlusion balloon device to be used in the event of an emergency, resistance was encountered and would not advance when trying to insert the balloon over the non-philips guidewire.A new non-philips guidewire was used, and the procedure was completed with no reported patient harm.This report captures the bridge balloon that would not advance over the guidewire; potential for harm if it was to recur in the event of an emergency.
Additional Manufacturer Narrative
A2- a6: patient information: not available from facility.B6/b7: patient information regarding relevant tests/laboratory data or medical history: not available from facility.H3/h6: the bridge was not returned; thus, no 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.
Additional Manufacturer Narrative
H3) the bridge catheter was returned for evaluation with a non-philips guidewire.Visual inspection found no unusual characteristics of the bridge device.During functional testing, a laboratory guidewire was inserted through the bridge from the proximal and distal ends, and no resistance was experienced.Using the returned non-philips guidewire, when attempting to load the bridge from the proximal and distal end, the guidewire experience significant resistance.H6) based on the device evaluation and investigation, the cause of the reported failure was determined to be the the non-philips guidewire which was out of specification, and interfered with proper function of the bridge device.There was no problems found with the bridge device, and has been determined to be a supplier related issue.Type of investigation code b01 replaced (from b17).Investigation findings code c19 replaced (from c20).Investigation conclusions code d20 replaced (from d14).All other codes remain applicable as listed in the initial mdr.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: 24734545
• Report Number: 3007284006-2026-00107
• Device Sequence Number: 16000256
• Product Code: MJN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 590-001
• Device Catalogue Number: 590-001
• Device Lot Number: 0303607861
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MERIT MEDICAL BRIDGE PREP KIT.
• Patient Sex: Unknown