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	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3) the bridge plus catheter was returned for evaluation with a non-philips guidewire.Visual inspection of the bridge plus found no unusual characteristics.Under magnification, the bridge plus guidewire lumen appeared unobstructed.Visual inspection of the returned guidewire found no apparent abnormalities and all measurements met specification.During functional testing, the guidewire was inserted through the bridge plus and passed completely through the guidewire lumen.Very slight resistance was noted at the hub interface; however, this resistance was minimal and did not impede full advancement of the guidewire.H6) based on the device evaluation and investigation, no device problem was found; therefore, the cause of the reported failure could not be established.Investigation findings code c19 replaced (from c21).Investigation conclusions code d15 replaced (from d16).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.
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.D9/h3/h6).The bridge plus device was returned; however, the device evaluation is pending.A supplemental report will be submitted once evaluation is completed.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), right atrial (ra), and left ventricular (lv) lead due to cied system/pocket infection.Spectranetics lld lead locking devices (llds) were inserted into each 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 non-philips guidewire, the balloon would not advance.A spectranetics bridge occlusion balloon was advanced successfully, and 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: 24581953
• Report Number: 3007284006-2026-00077
• Device Sequence Number: 13069580
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 590-002
• Device Catalogue Number: 590-002
• Device Lot Number: 0303599547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 03/19/2026
• 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: LV LEAD (MANUFACTURER, TYPE, MODEL UNK); MERIT MEDICAL BRIDGE PREP KIT 0.035 GUIDEWIRE; RA LEAD (MANUFACTURER, TYPE, MODEL UNK); RV LEAD (MANUFACTURER, TYPE, MODEL UNK); SPECTRANETICS LLD LEAD LOCKING DEVICE
• Patient Sex: Unknown