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

Model Number	M635TU70020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Transient Ischemic Attack (2109); Confusion/ Disorientation (2553); Thrombosis/Thrombus (4440)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was being performed.Initial intracardiac echocardiogram (ice) assessment obtained from the right ventricular outflow tract of the laa revealed no obvious thrombus.Trans-septal crossing was performed and two watchman truseal access systems (was) were used, a single curve and a double curve.The single curve was used for ice catheter advancement into the left atrium (la) and the double curve was used for the pigtail advancement into the laa.Contrast assessment was performed to confirm location.The ice catheter was then positioned to optimize visualization of the pigtail in the laa which then revealed a thrombus in the laa surrounding the pigtail and the distal sheath of the double curve was.A 27mm watchman flx laa closure device and delivery system (wds) was advanced with plans to trap the thrombus in the laa behind the closure device.Three attempts were made to implant the closure device, however attempts were unsuccessful as the positioning was not optimal and device was partially recaptured.The physicians then noted a second mobile thrombus outside the laa.The closure device was fully recaptured and aspiration was performed with the double curve was.All devices were removed from the la and the case was aborted.Heparin was administered and the patient was transferred to recovery for monitoring.
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was being performed.Initial intracardiac echocardiogram (ice) assessment obtained from the right ventricular outflow tract of the laa revealed no obvious thrombus.Trans-septal crossing was performed and two watchman truseal access systems (was) were used, a single curve and a double curve.The single curve was was used for ice catheter advancement into the left atrium (la) and the double curve was was used for the pigtail advancement into the laa.Contrast assessment was performed to confirm location.The ice catheter was then positioned to optimize visualization of the pigtail in the laa which then revealed a thrombus in the laa surrounding the pigtail and the distal sheath of the double curve was.A 27mm watchman flx laa closure device and delivery system (wds) was advanced with plans to trap the thrombus in the laa behind the closure device.Three attempts were made to implant the closure device, however attempts were unsuccessful as the positioning was not optimal and device was partially recaptured.The physicians then noted a second mobile thrombus outside the laa.The closure device was fully recaptured and aspiration was performed with the double curve was.All devices were removed from the la and the case was aborted.Heparin was administered and the patient was transferred to recovery for monitoring.It was further reported that there was only one thrombus visualized, first on the was sheath, then later seen in the laa, not two separate thrombus as previous reported.Additionally, aspiration of the thrombus was not attempted, as previously reported.The patient was reported to have awoken from the procedure with increased confusion.The patient was discharged five days from procedure.
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was being performed.Initial intracardiac echocardiogram (ice) assessment obtained from the right ventricular outflow tract of the laa revealed no obvious thrombus.Trans-septal crossing was performed and two watchman truseal access systems (was) were used, a single curve and a double curve.The single curve was used for ice catheter advancement into the left atrium (la) and the double curve was used for the pigtail advancement into the laa.Contrast assessment was performed to confirm location.The ice catheter was then positioned to optimize visualization of the pigtail in the laa which then revealed a thrombus in the laa surrounding the pigtail and the distal sheath of the double curve was.A 27mm watchman flx laa closure device and delivery system (wds) was advanced with plans to trap the thrombus in the laa behind the closure device.Three attempts were made to implant the closure device, however attempts were unsuccessful as the positioning was not optimal and device was partially recaptured.The physicians then noted a second mobile thrombus outside the laa.The closure device was fully recaptured and aspiration was performed with the double curve was.All devices were removed from the la and the case was aborted.Heparin was administered and the patient was transferred to recovery for monitoring.It was further reported that there was only one thrombus visualized, first on the was sheath, then later in the laa, not two separate thrombi as previous reported.Additionally, aspiration of the thrombus was not attempted, as previously reported.The patient was reported to have awoken from the procedure with increased confusion.The patient was discharged five days from procedure.It was further reported that during the procedure the patient had a right femoral hematoma which required no intervention.Additionally, as a result of the confusion, the patient underwent magnetic resonance imaging (mri) and computed tomography (ct) which revealed no stroke.The patient was diagnosed with transient ischemic attack (tia).

• Brand Name: WATCHMAN TRUSEAL ACCESS SYSTEM
• Common Device Name: 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14754587
• Report Number: 2134265-2022-07013
• Device Sequence Number: 6128154
• Product Code: DQY
• UDI-Device Identifier: 08714729965718
• UDI-Public: 08714729965718
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2025
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0029090229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 06/23/2022; 07/20/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/13/2022; 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male