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); Perforation of Vessels (2135)

Event Date 08/26/2021

Event Type  Injury  

Event Description

It was reported that an artery was punctured.A left atrial appendage (laa) closure procedure was performed.A watchman truseal access system was used and a 35mm watchman flx laa closure device was implanted.Upon removal of the access system, a large amount of bleeding was noted despite the groin closure device being deployed.Pressure was held for ten minutes without hemostasis being achieved, and continued bleeding at the groin site occurred.Vascular surgery was called, as the physician believed an artery may have been punctured.The patient was later brought to vascular surgery where a patch was placed which resolved the issue.The patients hemoglobin did drop 3 grams, so blood was given prior to vascular surgery.It was noted that vascular imaging was not used for groin puncture at the start of the case for any of the sheath placements.The patient did fine and was sent to the intensive care unit to recover.

Event Description

It was reported that an artery was punctured.A left atrial appendage (laa) closure procedure was performed.A watchman truseal access system was used and a 35mm watchman flx laa closure device was implanted.Upon removal of the access system, a large amount of bleeding was noted despite the groin closure device being deployed.Pressure was held for ten minutes without hemostasis being achieved, and continued bleeding at the groin site occurred.Vascular surgery was called, as the physician believed an artery may have been punctured.The patient was later brought to vascular surgery where a patch was placed which resolved the issue.The patients hemoglobin did drop 3 grams, so blood was given prior to vascular surgery.It was noted that vascular imaging was not used for groin puncture at the start of the case for any of the sheath placements.The patient did fine and was sent to the intensive care unit to recover.It was further reported that a hematoma occurred.

• 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: 12488934
• MDR Text Key: 271929931
• Report Number: 2134265-2021-11776
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• 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: 0027425411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Race: White