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

Model Number	TU-8001
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device damage occurred.The procedure was aborted.A left atrial appendage (laa) closure procedure was being performed.The patient was placed under general anesthesia.It was noted when preparing the single curve watchman fxd access system (was) outside of the patient, there was resistance encountered when inserting the dilator into the sheath and the dilator became deformed.The hemostatic valve was kept open on the was and the dilator was able to be inserted with a good amount of force.The was was inserted into the body and into the left atrium over a non-boston scientific (bsc) wire.The non-bsc wire and dilator was removed.Upon trying to insert the 24mm watchman flx delivery system and closure device (wds), there was resistance encountered multiple times.There was not another was available for use, so the procedure was aborted.No patient consequences were reported.
Event or Problem Description
It was reported that device damage occurred.The procedure was aborted.A left atrial appendage (laa) closure procedure was being performed.The patient was placed under general anesthesia.It was noted when preparing the single curve watchman fxd access system (was) outside of the patient, there was resistance encountered when inserting the dilator into the sheath and the dilator became deformed.The hemostatic valve was kept open on the was and the dilator was able to be inserted with a good amount of force.The was was inserted into the body and into the left atrium over a non-boston scientific (bsc) wire.The non-bsc wire and dilator was removed.Upon trying to insert the 24mm watchman flx delivery system and closure device (wds), there was resistance encountered multiple times.There was not another was available for use, so the procedure was aborted.No patient consequences were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned watchman fxd curve access system (was) (without dilator) was received for analysis and the reported event of resistance and device incompatibility was confirmed.The reported event of kink in the dilator was not confirmed as the dilator was not returned.Returned device consisted of a was with blood in the device.Visual inspection: no damage or defect found.Microscopic: no damage or defect found.Functional test: a dilator was inserted in the inner lumen of the was.The dilator was unable to advance.Borescope: inspection of the inner lumen found the liner delaminated.Product analysis confirmed the reported event as the liner was delaminating causing resistance with advancing the dilator.H6: evaluation codes updated to reflect device return findings.

• 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: 19712275
• Report Number: 2124215-2024-42381
• Device Sequence Number: 12912697
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: 00191506013806
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2026
• Device Model Number: TU-8001
• Device Catalogue Number: TU-8001
• Device Lot Number: 0031848574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male