MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY PRO; CATHETER, PERCUTANEOUS

Model Number	8101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, a dissection occurred in the left ventricle.An extended hook catheter (8104) was used to access the coronary sinus (cs), and the left ventricular (lv) lead was advanced along the cs using the 8104 model.This acuity pro catheter (8101) was chosen to advance the lv lead across a tight turn in the cs.This was not successful at first, therefore, contrast was injected through the 8101 catheter to assess, and the dissection was clearly visible on fluoroscopy.The physician suspected that this catheter was at fault, causing the dissection when the contrast was injected against the wall of the vessel.However, it was noted that it could have been due to the attempt to advance the lv lead across the narrow vessel.The 8101 model continued to be used to access another vessel below the point of dissection, before being exchanged for an 8103 model, which successfully entered the chosen vessel branch, and the lv lead was successfully implanted.The related cardioverter defibrillator, right atrial lead, and the right ventricular lead were also successfully implanted.A post implant echocardiogram was performed to confirm that there was no serious fluid buildup around the heart due to the dissection, which showed no concerning complications.The patient's device was checked the next day and it was satisfactory, and the patient was discharged the next day per the original plan.No additional adverse patient effects were reported.This catheter is not expected for return.
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that during the procedure, a dissection occurred in the left ventricle.An extended hook catheter (8104) was used to access the coronary sinus (cs), and the left ventricular (lv) lead was advanced along the cs using the 8104 model.This acuity pro catheter (8101) was chosen to advance the lv lead across a tight turn in the cs.This was not successful at first, therefore, contrast was injected through the 8101 catheter to assess, and the dissection was clearly visible on fluoroscopy.The physician suspected that this catheter was at fault, causing the dissection when the contrast was injected against the wall of the vessel.However, it could have been due to the attempt to advance the lv lead across the narrow vessel.The 8101 model continued to be used to access another vessel below the point of dissection, before being exchanged for an 8103 model, which successfully entered the chosen vessel branch, and the lv lead was successfully implanted.The crt-d, right atrial lead, and the right ventricular lead were also successfully implanted.A post implant echocardiogram was performed to confirm that there was no serious fluid buildup around the heart due to the dissection, which showed no concerning complications.The patient's device was checked the next day and it was satisfactory, and the patient was discharged the next day per the original plan.No additional adverse patient effects were reported.This catheter is not expected for return.

• Brand Name: ACUITY PRO
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC MAPLE GROVE; 2 scimed place; maple grove MN 55311
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16534747
• Report Number: 2124215-2023-11776
• Device Sequence Number: 5993585
• Product Code: DQY
• UDI-Device Identifier: 08714729932468
• UDI-Public: 08714729932468
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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 Expiration Date: 02/23/2024
• Device Model Number: 8101
• Device Catalogue Number: 8101
• Device Lot Number: 28926629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male