MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPULSE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 08/29/2018

Event Type  Injury  

Event Description

It was reported a perforation and pericardial effusion with tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system and pigtail catheter were advanced into the laa and the pigtail was on the back wall of the laa.A contrast shot was performed and revealed a perforation.The patient developed a pericardial effusion with tamponade in the superior posterior area pericardial space.A pericardiocentesis was performed.The patient was stable and was discharged from the hospital.

• Brand Name: IMPULSE
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPORATED; 5950 nancy ridge drive; san diego CA 92121
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7906728
• MDR Text Key: 121635779
• Report Number: 2134265-2018-61269
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR