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

Lot Number 0022297680

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

Patient Problem Blood Loss (2597)

Event Date 12/17/2019

Event Type  Injury  

Event Description

It was reported via the flxibility study that blood loss occurred.A left atrial appendage (laa) closure procedure was performed.A watchman truseal access system (was) was positioned and a watchman laa closure device & delivery system (wds) was implanted.Post procedure, in the catheter lab, the patient was noted to have a massive secondary bleed under the pressure bandage at the incision site (z suture), for which a forced volume substitution as well as catecholamine therapy was given.The bleeding ceased on manual pressure and there was no hematoma.A new pressure bandage was applied.One day prior to the procedure, baseline lab investigations revealed hemoglobin value of 6.7 mmol/l (reference range: 8.7 to 10.9 mmol/l) and hematocrit value of 0.36 (reference range: 0.36-0.48).On the day of the procedure lab investigations revealed hemoglobin (hb) value of 5.1 mmol/l and hematocrit value of 0.27.The day following the procedure, the patient was transfused with 2 units of red cell concentrates (rcc).Post transfusion the patient was transferred to the ward for further monitoring.At transfer to the ward the patient was alert, adequate, but still was on catecholamine therapy and the catecholamine dose was further increased.After stabilization, the catecholamine therapy was reduced in stages.Transfusion had no complications and there was an adequate hb increase, but over the further course there was another mild drop which did not required further transfusion.The patient was monitored closely.No other clinical signs of bleeding were noted.On the same day, duplex ultrasound revealed a small hematoma at the incision site and no active bleeding was noted with unremarkable flow in the right femoral bifurcation.No evidence of pseudoaneurysm or an av shunt in the area of the puncture site was noted.The patient always remained alert and adequate over the further course and the catecholamine therapy was stopped.The patient was discharged in a stable cardiopulmonary state to valued ongoing outpatient care on aspirin and clopidogrel.

• 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: 10504930
• MDR Text Key: 206100136
• Report Number: 2134265-2020-11210
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2021
• Device Lot Number: 0022297680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR