MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN TRUSEAL ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number M635TU70020

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 08/06/2021

Event Type  Injury  

Event Description

It was reported that the patient had a hematoma.A left atrial appendage (laa) closure procedure was being performed.A watchman truseal access system (was) was positioned and a 24mm watchman flx laa closure device & delivery system (wds) were used.During the procedure a 20mm watchman flx device was deployed but did not meet release criteria.This device was fully recaptured and removed from the patient.The physician then successfully completed the procedure by implanting a new 24mm watchman flx device in the laa of the patient.There were no complications that occurred during the procedure.After the procedure was completed the patient developed a groin hematoma that required manual pressure to be applied.The patient also experienced a low blood pressure at this time.A thrombin injection was given to the patient but it did not resolve the hematoma.So, the patient was brought to the operating room to repair the femoral artery.In addition the patient received blood products that day.The patient has since been discharged home doing fine.

• Brand Name: WATCHMAN TRUSEAL ACCESS SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12388769
• MDR Text Key: 268846076
• Report Number: 2134265-2021-10607
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729965718
• UDI-Public: 08714729965718
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0027379196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR