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	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.During a persistent atrial fibrillation procedure, this emerge balloon catheter along with an amplatz stiff guidwire were selected.The decision was made to catheterize the marshall vein to check for possible alcoholization, before beginning reconstruction of the left atrium.The vein could be seen upon contrast injection on fluoroscopy.The vein was thin and difficult to reach with the guide catheter, the physician preferred to give up the alcoholization.Transseptal puncture was performed with no difficulty.However, prior to ablation, the patient became slightly hypotensive.An echography was performed and a small circumferential effusion was noticed around the right atrium, with no compression of the heart.In the meantime, an ablation of the posterior wall at the superior vena cava was performed.A second echography was performed15 minutes later, which revealed an increase of the effusion.The procedure was stopped and a pericardiocentesis was performed to stabilize the patient.The patient was transferred to the intensive cardiologic care unit where they remained stable.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12129489
• Report Number: 2134265-2021-08567
• Device Sequence Number: 17250541
• Product Code: DQX
• UDI-Device Identifier: 08714729741350
• UDI-Public: 08714729741350
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: 02/02/2024
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0026738692
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention