MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER; 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	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's date of birth unk.Other relevant history unk.The device was not returned, thus no investigation could be completed.
Event or Problem Description
A lead extraction procedure was scheduled to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia (cied system/pocket infection).Prior to beginning the case, a spectranetics bridge occluding balloon was being prepped to be used in the event an emergency occurred during the procedure.However, when the physician attempted to place the bridge balloon onto the 0.35 guide wire, the bridge would not track/advance over the wire.A new bridge balloon was opened and it worked perfectly.The procedure was completed successfully with no reported patient harm.This report captures the first bridge balloon that would not track/advance over the guide wire and the potential for harm if it was to recur in the event of an emergency.
Additional Manufacturer Narrative
D9): the device was returned to the manufacturer on 11 jan 2022.G3): device evaluation and investigation completed 10 feb 2022.H3): device evaluation: the device was returned and evaluated by a cross functional team.The guide wire was returned with the bridge device, observed exiting out of the device''s guide wire port.The guide wire was stuck 27 mm from the distal tip of the device.The straight end and j tip of the guide wire looked to be in good working condition.No damage was observed on the bridge device; however, biologics were seen in the guide wire lumen.The bridge balloon and inflation port were in good working condition.Pulling the guide wire from the proximal end of the bridge device, the outer coils of the guide wire unraveled.Flushing of the bridge guide wire port did not successfully remove the guide wire.In order to determine the cause, further dissection of the bridge inner lumen included using a mandrel, removing the strain relief, and cutting sections of the lumen was performed.Ultimately, the bridge lumen was cut vertically and an unknown fibrous substance was removed from the inner lumen.With this substance removed, the guide wire was able to pass through the bridge inner lumen.A new guide wire was backloaded and the bridge inner lumen was patent.The substance was identified as biologics (fibrous tissue).There is no indication of a design or production issue, and no indication of a use related failure.The failure was caused by fibrous tissue that became stuck in the guide wire while passing an obstruction within the patient''s vasculature.The buildup of tissue on the guide wire prevented the bridge device from advancing on the guide wire.This event has been determined to be patient condition related (fibrous tissue causing the failure), not device related.

• Brand Name: SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13119745
• Report Number: 1721279-2021-00255
• Device Sequence Number: 4665299
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: (01)00813132024840(17)231026(10)FMN21K26A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/08/2021

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: 10/26/2023
• Device Model Number: 590-001
• Device Catalogue Number: 590-001
• Device Lot Number: FMN21K26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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 4015 RA PACING LEAD; MEDTRONIC 4034 RV PACING LEAD; SECOND SPECTRANETICS BRIDGE BALLOON CATHETER
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander