MAUDE Adverse Event Report: SPECTRANETICS CORPORATION 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	Thrombosis/Thrombus (4440)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non-function.No imaging was performed before the extraction.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 as a rescue measure.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.Beginning with a spectranetics glidelight laser sheath and a spectranetics visisheath dilator sheath, the rv lead was extracted successfully.The bridge balloon remained in the patient for approximately one hour while the case was completed; emergent use of bridge was not required.The bridge was then removed from the patient, with no thrombus observed.However, post-procedure, the physician noticed a large clot in the ra on echo, and was concerned it may have had to do with the bridge in-dwell time within the patient.The clot dissolved on its own, with no further intervention or treatment required.No patient injury was reported, and the patient was reportedly doing well.This report captures the staged bridge balloon within the patient for approximately 1 hour, which may have caused or contributed to the clot.There was no alleged malfunction of any spectranetics device in use during the procedure.
Additional Manufacturer Narrative
A4): patient's weight unk.B7): other relevant history unk.D4): device lot number, expiration date unk.Partial udi populated.H4): device manufacture date unk because lot number unk.H6): although thrombus is a known inherent risk of device, the spectranetics ifu 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/failure to follow instructions.Per physician, defibrillation threshold testing (performed on the new lead) could have caused the clot.Additionally, philips clinical assessment noted that other concomitantly used devices in the heart, and/or rebound hypercoagulability due to discontinuation of eloquis five days prior to the procedure, could also have caused/contributed to the clot.Therefore, the cause of the reported event 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.
Additional Manufacturer Narrative
D4): correction: removing primary di number from udi# field.The lot number was not provided, thus an entire udi# is unavailable.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): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 18143601
• Report Number: 3007284006-2023-00061
• Device Sequence Number: 6588384
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: 00813132024840
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/29/2024

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
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 07/29/2024
• 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: BIOTRONIK 365500 RV ICD LEAD.; BRIDGE PREP KIT GUIDE WIRE.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS LEAD LOCKING DEVICE.; SPECTRANETICS VISISHEATH DILATOR SHEATH.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White