BOSTON SCIENTIFIC - GALWAY WATCHMAN® ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
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Model Number M635TS20060 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was performed.A watchman® access system was successfully prepared for use.The transeptal puncture was performed and the amplatz super stiff wire was positioned to the pulmonary vein.The watchman® access system was advanced and the dilator and wire were removed.However, the hemostasis valve on the access system could not be closed and blood was flowing out.There was about 40-60 ml of blood lost.They attempted to unscrew and close the valve three times, but were unsuccessful.Therefore, they exchanged for a new access system to successfully complete the procedure.There were no patient complications and the patient's status is stable.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of the watchman access sheath (was) and dilator which was not inside the was as received.The valve was opened as received and blood was on the device.The valve, hub, shaft, and tip were examined.The shaft was kinked 4cm from the strain relief.Microscopic examination of the threads of the was revealed they were damaged/cross threaded.It could not be determined when the thread damage occurred.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Functional testing of the valve confirmed the ability to completely close the valve with forward force.Water was injected into the was by attaching a syringe filled with water.There were no leaks or air bubbles observed during water injection.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
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Event Description
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It was reported a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was performed.A watchman® access system was successfully prepared for use.The transeptal puncture was performed and the amplatz super stiff wire was positioned to the pulmonary vein.The watchman® access system was advanced and the dilator and wire were removed.However, the hemostasis valve on the access system could not be closed and blood was flowing out.There was about 40-60 ml of blood lost.They attempted to unscrew and close the valve three times, but were unsuccessful.Therefore, they exchanged for a new access system to successfully complete the procedure.There were no patient complications and the patient's status is stable.
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