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	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A lead extraction procedure commenced (extraction indication and lead information unk).During prophylactic staging of a spectranetics bridge occlusion balloon device to be used in the event of an emergency, it was discovered the balloon became stuck on a merit medical.035 guide wire.A new bridge balloon advanced over the guide wire with success prior to the case.No patient injury reported.This report captures the bridge balloon that became stuck and would not advance over the guide wire; potential for harm if it was to recur in the event of an emergency.
Additional Manufacturer Narrative
Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was not returned, thus no investigation could be completed.The cause of 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.
Additional Manufacturer Narrative
D9): the device was returned to the manufacturer 06feb2023.G3): device evaluation and investigation completed 24feb2023.H3): the bridge was returned for evaluation, with a guide wire inside the device, with biologics present inside the guide wire lumen.Two kinks were observed on the lumen, 135 mm and 530 mm from the distal tip.Initially, the guide wire could not be removed from the device.Visual inspection found biologics present in the lumen, approximately 300 mm in length, extending to the distal tip.Using a syringe filled with water, attempts were made to flush the guide wire lumen.With excessive force applied, biologics and a few drops of water were expelled from the distal tip.Using pliers and excessive force, the guide wire was able to be removed through the proximal end of the device, with biologics observed.When loading a laboratory 0.035 guide wire from the proximal end, slight resistance was encountered at the locations of both kinks, but was successfully threaded through the entire length of the guide wire lumen.H6): type of investigation code changed to 10 (from 4114).Investigation findings code changed to 3211 (from 3221).Investigation conclusions code changed to 50 (from 67).All other codes remain applicable to the event.The cause of the reported failure was likely due to excessive biologics, which prevented the bridge from advancing over the guide wire.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: 16117479
• Report Number: 1721279-2023-00007
• Device Sequence Number: 5667086
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: (01)00813132024840(17)240922(10)FMN22J22A
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/09/2023

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: 09/22/2024
• Device Model Number: 590-001
• Device Catalogue Number: 590-001
• Device Lot Number: FMN22J22A
• 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: 01/06/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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: LEAD(S) MANUFACTURER/MODEL UNK.; MERIT MEDICAL .035 GUIDE WIRE.
• Patient Age: 33 YR
• Patient Sex: Male