MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION BRIDGE PLUS OCCLUSION BALLOON; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	590-002
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B6) relevant tests/laboratory data - not available from facility.H3) the bridge plus device was returned for evaluation with the non-philips guidewire.Visual inspection found no unusual characteristics of the bridge device.Under magnification, the bridge guidewire lumen was not obstructed, and the uv adhesive application during assembly of the hub and strain relief was correct.Visual inspection of the returned guidewire found no apparent abnormalities.During functional testing, the guidewire was inserted through the bridge guidewire lumen, but resistance was encountered at three pinch points.It was noted that the proximal end/tip of the guidewire was oversized compared to the remainder of the guidewire.Additionally, a laboratory guidewire was inserted into the bridge guidewire lumen with no resistance.H6) based on the device evaluation and investigation, the cause of the reported failure was determined to be the oversized proximal end/tip of the non-philips guidewire, which interfered with proper function of the bridge plus device.There was no problems found with the bridge plus device.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) lead due to non-function.A right atrial (ra) lead was present within the patient but was not targeted for extraction.A spectranetics lld lead locking device was inserted into the lead to provide traction.During prophylactic staging of a spectranetics bridge plus occlusion balloon device to be used in the event of an emergency, resistance was encountered when trying to insert the balloon over the.035 non-philips guidewire but was able to proceed.Once reaching the hub of the balloon, the guidewire would no longer advance or exit the end of the wire port, thus removed from the patient.A spectranetics bridge occlusion balloon was advanced successfully over the guidewire.The procedure was completed with no reported patient harm.This report captures the bridge plus balloon that would not advance over the guidewire; potential for harm if it was to recur in the event of an emergency.

• Brand Name: BRIDGE PLUS OCCLUSION BALLOON
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 23889079
• Report Number: 3007284006-2025-00271
• Device Sequence Number: 9622814
• Product Code: MJN
• UDI-Device Identifier: 00810060550816
• UDI-Public: (01)00810060550816(11)251016(17)271016(10)0303599547
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K251358
• 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): 12/24/2025

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: 590-002
• Device Catalogue Number: 590-002
• Device Lot Number: 0303599547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/24/2025
• 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: BOSTON SCIENTIFIC 0292 RV ICD LEAD; BOSTON SCIENTIFIC 4135 RA PACING LEAD; SPECTRANETICS LLD LEAD LOCKING DEVICE
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White