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

Model Number	590-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	02/03/2023
Type of Reportable Event	Death
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and right ventricular (rv) lead for an upgrade to a biventricular icd system (patient had significant medical history/comorbidities).Prior to the procedure, a spectranetics bridge occlusion balloon was prophylactically ''staged'' within the patient's inferior vena cava (ivc).In the event of an emergency, the bridge balloon could be positioned and inflated quickly within the superior vena cava (svc) to provide occlusion of the svc as a rescue measure.Spectranetics devices (glidelight laser sheath, lead locking devices (llds)) were used to successfully extract both leads.Re-implantation of a new rv and the addition of an lv lead was completed.The bridge balloon remained in the patient for 1 hour, 42 minutes while the case was completed; use of bridge was not required.The bridge was then removed from the patient, with no thrombus observed.The patient survived the procedure, and laid flat for the mandated 4 hours prior to being discharged.As the patient was getting dressed,  he suddenly collapsed, and a cardiac code was called.During the code, transesophageal echocardiography (tee) was used to detect for any injuries; no effusions, tamponade or suspect for bleeding was noted.The patient's ekg showed pulseless electrical activity (pea).After approximately one hour of rescue effort, the patient was pronounced dead.The patient's wife declined an autopsy.The physician had a high suspicion that the bridge in-dwell time could have caused the patient's death (potential embolism).This report captures the staged bridge balloon within the patient for 1 hour 42 minutes.The possibility of the bridge in-dwell time (potential embolism) cannot be ruled out as causing or contributing to the patient's death.However, other devices (guidewire, sheath) were used concomitantly with the bridge balloon.There was no alleged malfunction of any spectranetics device in use during the procedure.
Additional Manufacturer Narrative
Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.Embolization is a known risk of complication with use of the bridge balloon.Additionally, in the spectranetics ifu, it states, "prophylactic placement of the bridge occlusion balloon is recommended after all lead extraction preparation has been completed and just before the use of any extraction sheaths in order to minimize balloon dwell time." the physician prophylactically staged the bridge balloon before lead preparation was complete, which was determined to be use error.In addition to the bridge, other devices were also used (sheath, guide wire) which could have caused or contributed to the event.The cause for the reported event could not be established, since an autopsy was not performed.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: 16499763
• Report Number: 1721279-2023-00034
• Device Sequence Number: 6366556
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: 00813132024840
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 590-001
• Device Catalogue Number: 590-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 12F INTRODUCER SHEATH FROM BRIDGE PREP KIT; BOSTON SCIENTIFIC 4135 RA PACING LEAD; BOSTON SCIENTIFIC 4136 RV PACING LEAD; GUIDE WIRE FROM BRIDGE PREP KIT; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Death
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White