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

Model Number	590-001
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient''s weight unk.Other relevant history unk.The device has been returned to the manufacturer but the evaluation has not yet begun.A supplemental mdr will be submitted after the device evaluation and investigation have been 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) lead due to non function.During prophylactic staging of a spectranetics bridge occlusion balloon device to be used in the event of an emergency, it was discovered the device was unable to advance over the bridge prep kit guide wire.Attempts were made to advance the bridge over a non manufacturer''s guide wire without success.A new bridge balloon was advanced successfully over the non manufacturer''s guide wire.The procedure was completed with no reported patient harm.This report captures the bridge balloon that would not advance over the guide wires; potential for harm if it was to recur in the event of an emergency.
Event or Problem Description
This event is no longer reportable for the bridge balloon, reported in the initial mdr that it would not advance over the guide wires.At device evaluation, both the returned guide wire and a laboratory guide wire advanced successfully through the bridge balloon.There is no potential for harm if the event was to recur.
Additional Manufacturer Narrative
B5/h2): this event is no longer reportable.G3): device evaluation and investigation were completed 05apr2023.H3): the bridge device and guide wire were returned.Visual inspection found no damage on the bridge device.However, the returned guide wire had a slight bend with multiple kinks observed.During functional testing, both the returned guide wire and an.035 laboratory guide wire advanced successfully throughout the entire length of the bridge.  h6): based on the device evaluation, the reported complaint could not be replicated.Certain h6 codes submitted on the initial mdr are no longer applicable and updated with: investigation findings code 213 (replaces 3233), and investigation conclusions code 67 (replaces 11).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: SPECTRANETICS BRIDGE OCCLUSION BALLOON
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 16658264
• Report Number: 1721279-2023-00055
• Device Sequence Number: 1700588
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: (01)00813132024840(17)240825(10)FMN22H25A
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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 Expiration Date: 08/25/2024
• Device Model Number: 590-001
• Device Catalogue Number: 590-001
• Device Lot Number: FMN22H25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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: GUIDE WIRE MANUFACTURER/SIZE UNK; SPECTRANETICS BRIDGE PREP KIT; ST. JUDE MEDICAL 7122 RV ICD LEAD; TRACTION PLATFORM, MANUFACTURER/TYPE UNK
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American