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 Problem Blood Loss (2597)

Event Date 05/28/2020

Event Type  Injury  

Event Description

It was reported that the patient was bleeding from the access site.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were used.The procedure was completed successfully and the closure device was implanted in the laa of the patient.Following the end of the procedure the patient experienced bleeding from both groin access sites, one for the was and the other for the intraprocedural imaging catheter.The bleeding required additional manual pressures as well as blood and platelets being given to the patient.The patient recovered from this event and has since been discharged from the hospital.

• 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: 10187141
• MDR Text Key: 196217567
• Report Number: 2134265-2020-08080
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2023
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0024994748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention