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); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 12/02/2019

Event Type  Injury  

Event Description

Option study.It was reported that there was a hematoma and bleeding that occurred.On (b)(6) 2019 a left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 35mm watchman flx laa closure device & delivery system (wds) were used.The patient was ablated using the pulmonary vein isolation ablation technique.During the procedure, heparin, apixaban and prophylactic antibiotics were administered.The patient underwent successful placement of a 35 mm watchman flx device with a complete laa seal and deployed device diameter of 26mm.Post procedure, the patients blood pressure dropped to 63/42 and a large left groin hematoma was also noted.The hematoma was treated with compression and hospitalization was prolonged.Ct abdomen and pelvis revealed left sided retroperitoneal bleed ranging from 10.2 x 3.6 x 5.5 cm.The retroperitoneal bleed was complicated due to watchman device placement.At the time of the event, the patient was on apixaban and aspirin which were temporarily withheld.The patient was transfused with 2 units of prbc and 2.5l of fluid were given.On (b)(6) 2019, the patient was re-started on anticoagulant medications.On (b)(6) 2019, the patient was discharged home on apixaban and aspirin.On (b)(6) 2019, the bleeding was considered recovered/resolved.On (b)(6) 2020 the hematoma event was considered recovered/resolved.

• 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: 9849875
• MDR Text Key: 184050049
• Report Number: 2134265-2020-03387
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2022
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0024270508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR