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

Model Number	590-001
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4): patient's weight unk.B6): relevant tests/laboratory data unk.H3/h6): the device was not returned for evaluation, thus no investigation could be performed and the reported failure could not be confirmed.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 atrial (ra) and a right ventricular (rv) lead due to bacteremia.During preparation to stage a spectranetics bridge occlusion balloon to be used in the event of an emergency, it was observed that the balloon was enlarged at the tip, when the protective sleeve was removed.It was considered to be too enlarged to insert through the femoral sheath, so another bridge balloon was opened and used to prophylactically stage within the patient.The procedure was completed with no reported patient harm.This report captures the bridge balloon which was enlarged at the tip, potential for harm if it was to recur in the event of an emergency.
Additional Manufacturer Narrative
D9): the device was returned 01aug2023.G3): device evaluation and investigation were completed 17aug2023.H3): the bridge device was returned without the protective sheath.Visual inspection found the balloon was wrinkled and accordioned at the distal tip.The distal end of the balloon was flared, compared to the appearance of the rest of the balloon.Using a 0.035" laboratory guide wire, the device was confirmed to be patent but significant resistance was encountered when directly under the balloon.When loading the bridge through a 12f laboratory introducer sheath from a bridge prep kit, advancement was achieved through the entire sheath, with slight resistance noted upon advancement and withdrawal, as expected.H6): based on device evaluation and investigation, the cause of the reported failure and balloon deformity could not be established.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): 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: 17292876
• Report Number: 1721279-2023-00121
• Device Sequence Number: 11761328
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: (01)00813132024840(17)250130(10)FMN23A30A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: 01/30/2025
• Device Model Number: 590-001
• Device Catalogue Number: 590-001
• Device Lot Number: FMN23A30A
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; SECOND SPECTRANETICS BRIDGE OCCLUSION BALLOON; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White