MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER

Model Number	39615
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a pericardial effusion, perforation and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.The patient's atrium was noted to be small and the transeptal puncture was complex.After the transseptal puncture, an amplatz super stiff guidewire was advanced to the left atrium and it was noted a pericardial effusion occurred.It was initially minimal and during the procedure it did not increase.The procedure continued and was completed successfully with a watchman flx laa closure device implanted.One day post procedure, the pericardial effusion was noticed to have increased so a pericardiocentesis was performed to drain the blood.The patient fully recovered and was not admitted to the hospital beyond the standard of care.
Event or Problem Description
It was reported a pericardial effusion, perforation and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.The patient's atrium was noted to be small and the transeptal puncture was complex.After the transseptal puncture, an amplatz super stiff guidewire was advanced to the left atrium and it was noted a pericardial effusion occurred.It was initially minimal and during the procedure it did not increase.The procedure continued and was completed successfully with a watchman flx laa closure device implanted.One day post procedure, the pericardial effusion was noticed to have increased so a pericardiocentesis was performed to drain the blood.The patient fully recovered and was not admitted to the hospital beyond the standard of care.It was further reported that the patient was discharged from the hospital one day post procedure.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14989186
• Report Number: 2124215-2022-25271
• Device Sequence Number: 1584457
• Product Code: DQX
• UDI-Device Identifier: 08714729741350
• UDI-Public: 08714729741350
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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: 03/06/2025
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0028998700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 58 KG