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

Model Number	M635TU80010
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the interior polytetrafluoroethylene (ptfe) liner delaminated from the sheath.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a watchman flx laa closure device & delivery system (wds) was selected for use.After deployment of the wds, an echo density was observed on transesophageal echocardiography (tee).It was assumed to be a thrombus; however, it was an abnormal appearing thrombus.Aspiration of the sheath was performed without success.A watchman closure device was in place at the time but was suboptimal positioning and a recapture was necessary.After recapture, the wds was removed from the patient body and was unremarkable.Further aspiration of the was sheath was performed without any evidence of thrombus.At this point the echo density was no longer observed on tee.Upon attempting to advance a new wds, resistance was felt by the physician, and the decision was made to remove the was sheath from the body.In troubleshooting, the dilator was reintroduced into the sheath with force and a clear plastic appearing substance was expelled from the sheath that appeared to be attached to the interior.It appeared that the interior ptfe liner delaminated from the sheath.It was noted that the material from the sheath did partially embolize into the patient as it appeared that part of the liner was entangled in some of the pectinate.No attempt was made to remove the liner from the pectinate.The physician decided to go back up with a new was sheath and closure device and deployed over the top of the material ultimately trapping it in the appendage.The sheath was set aside, and the procedure was then successfully completed with an alternate sheath and device.There were no patient complications, tissue damage, pericardial effusion or issues observed.The patient had a neurological exam completed post procedure which confirmed there were no patient complications.
Event or Problem Description
It was reported the interior polytetrafluoroethylene (ptfe) liner delaminated from the sheath.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a watchman flx laa closure device & delivery system (wds) was selected for use.After deployment of the wds, an echo density was observed on transesophageal echocardiography (tee).It was assumed to be a thrombus; however, it was an abnormal appearing thrombus.Aspiration of the sheath was performed without success.A watchman closure device was in place at the time but was suboptimal positioning and a recapture was necessary.After recapture, the wds was removed from the patient body and was unremarkable.Further aspiration of the was sheath was performed without any evidence of thrombus.At this point the echo density was no longer observed on tee.Upon attempting to advance a new wds, resistance was felt by the physician, and the decision was made to remove the was sheath from the body.In troubleshooting, the dilator was reintroduced into the sheath with force and a clear plastic appearing substance was expelled from the sheath that appeared to be attached to the interior.It appeared that the interior ptfe liner delaminated from the sheath.It was noted that the material from the sheath did partially embolize into the patient as it appeared that part of the liner was entangled in some of the pectinate.No attempt was made to remove the liner from the pectinate.The physician decided to go back up with a new was sheath and closure device and deployed over the top of the material ultimately trapping it in the appendage.The sheath was set aside, and the procedure was then successfully completed with an alternate sheath and device.There were no patient complications, tissue damage, pericardial effusion or issues observed.The patient had a neurological exam completed post procedure which confirmed there were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr.: a watchman fxd curve access system (was) was returned for device analysis.The device was visually examined.Visual and borescope inspection revealed the inner liner delaminated.A review of the media provided confirms the reported event as the inner liner is separated from the access system.Materials testing and characterization (mtac) testing was also performed on the returned device.Mtac test results indicate the root cause of ptfe liner delamination is insufficient interface contact between the pebax tie layer of the liner and the pebax sheath resulting in decreased adhesion between the liner and the sheath compared to control samples.This decreased adhesion might be induced by incomplete reflow or less constraint from the shrink tubing, resulting in the incomplete fusion of the pebax tie layer of the liner to the pebax sheath.Product and media analysis confirmed the reported event as the inner liner was delaminated.

• Brand Name: WATCHMAN FXD CURVE? ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20238485
• Report Number: 2124215-2024-57710
• Device Sequence Number: 7961047
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: (01)00191506013806(17)261017(10)32666154
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K212228
• 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
• Report Date (Section B): 04/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M635TU80010
• Device Catalogue Number: M635TU80010
• Device Lot Number: 0032666154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male