FDA Adverse Event Injury Summary report: N

WATCHMAN FXD CURVE ACCESS SYSTEM

MDR report key: 19556788 · Received June 18, 2024

Report

Report Number
2124215-2024-35834
Event Type
Injury
Date Received
June 18, 2024
Date of Event
June 6, 2024
Report Date
June 17, 2024
Manufacturer
BOSTON SCIENTIFIC CORPORATION
Product Code
DQY
UDI-DI
00191506013813
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MI, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IT WAS REPORTED THAT A PERICARDIAL EFFUSION AND PERFORATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A WATCHMAN FLX CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. THE PHYSICIAN PERFORMED THE TRANSEPTAL PUNCTURE (TSP) WITH THE VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT. DURING TRANSSEPTAL CROSSING THE PHYSICIAN SUCCESSFULLY CROSSED THE INTERATRIAL SEPTUM (IAS) WITH THE RF PIGTAIL WIRE FROM A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT. IT WAS NOTED THAT THE IAS WAS THICK AND CAUSED THE DILATOR AND WAS SHEATH TO GET HUNG UP. IN AN ATTEMPT TO CROSS AND DILATE THE THICKENED IAS, THE PHYSICIAN INCREASED FORWARD PRESSURE ON THE IAS WITH THE DILATOR AND WAS SHEATH, HOWEVER WHEN DOING SO THE WAS SHEATH AND DILATOR SUDDENLY AND UNEXPECTEDLY ADVANCED THROUGH THE IAS. DUE TO THE SUDDEN MOVEMENT OF THE EQUIPMENT CROSSING THE IAS, COMBINED WITH THE INCREASED PRESSURE APPLIED, THE DILATOR WENT TOO FAR INTO THE LEFT ATRIUM (LA) AND PERFORATED THE POSTERIOR WALL OF THE LA. A PERICARDIAL EFFUSION WAS IMMEDIATELY NOTICED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). VERY SOON AFTER THE EFFUSION WAS NOTICED, THE PATIENTS PRESSURE DROPPED SIGNIFICANTLY INDICATING CARDIAC TAMPONADE. CARDIOTHORACIC (CT) SURGERY WAS NOTIFIED, AND HEPARIN WAS REVERSED. THE PHYSICIAN ATTEMPTED A PERICARDIOCENTESIS BUT STRUGGLED TO GET THE EQUIPMENT INTO THE PERICARDIAL SPACE. THE PATIENT VITALS WERE BEING MAINTAINED WITH MEDICATION WHILE THE PHYSICIAN CONTINUED TO NAVIGATE INTO THE PERICARDIAL SPACE. A PERICARDIAL DRAIN WAS PLACED, AND IT WAS NOTED THAT THE PERICARDIAL SPACE HAD THROMBOSED ENOUGH TO SIGNIFICANTLY SLOW THE BLEEDING FROM THE PERFORATION AND THE PATIENT HEMODYNAMICS STARTED TO STABILIZE WITHOUT THE USE OF EXTRA MEDICATION. DUE TO THE BLOOD IN THE PERICARDIAL SPACE BEING MOSTLY CLOTTED, NOT MUCH FLUID/BLOOD WAS ABLE TO BE DRAINED. THE PHYSICIAN AND CT SURGEON DISCUSSED OPTIONS AND ULTIMATELY DECIDED THE PATIENT DID NOT REQUIRE SURGICAL INTERVENTION AT THAT TIME AS THEY WERE STABLE AND THE BLOOD IN THE PERICARDIAL SPACE WAS THROMBOSED. THE PATIENT WAS ADMITTED TO THE SURGICAL INTENSIVE CARE UNIT (SICU) WHILE STILL INTUBATED AND WITH THE DRAIN REMAINING IN PLACE. THE PERICARDIAL EFFUSION WAS NOTICED AT 10:15AM. AT APPROXIMATELY 3:30PM, THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS EXTUBATED. THE PATIENT REMAINED IN THE SICU TO CONTINUE MONITORING. PATIENT STATUS. THE PATIENT RECOVERED AND WAS DISCHARGED TWO (2) DAYS POST PROCEDURE, ON (B)(6) 2024.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2315445 WATCHMAN FXD CURVE ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL DQY BOSTON SCIENTIFIC CORPORATION TU-8002 0032725857 00191506013813

Patients

Seq Age Sex Outcome Treatment
1 85 YR Female Required Intervention| H