BOSTON SCIENTIFIC - MAPLE GROVE WATCHMAN® ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
|
Back to Search Results |
|
Model Number M635TU20060 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/01/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was being performed.The hemostasis valve of the watchman® access system would not close; therefore, leaking blood.The patient lost about 20 cc of blood.A pigtail catheter was in the was initially, but was removed to assess the valve better.The physician attempted to draw blood from the side port to make sure the side port tubing would not fill with air and blood.The physician controlled the blood loss by using thumb pressure; however, the device was removed and exchanged for a another access system to complete the procedure.No patient complications were reported and the patient's status was fine.
|
|
Manufacturer Narrative
|
Device evaluated by mfr: returned product consisted of the watchman access sheath (was).Analysis revealed numerous kinks along the shaft of the device.The valve was opened as received.Microscope examination of the valve did not reveal any damage or irregularities; however, it was noted that the threads of the was were damaged/cross threaded.It could not be determined when the thread damage occurred.Microscopic examination revealed the tip was damaged.Functional testing of the valve confirmed the ability to completely close the valve with minimal 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.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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).
|
|
Event Description
|
It was reported a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was being performed.The hemostasis valve of the watchman® access system would not close; therefore, leaking blood.The patient lost about 20 cc of blood.A pigtail catheter was in the was initially, but was removed to assess the valve better.The physician attempted to draw blood from the side port to make sure the side port tubing would not fill with air and blood.The physician controlled the blood loss by using thumb pressure; however, the device was removed and exchanged for a another access system to complete the procedure.No patient complications were reported and the patient's status was fine.
|
|
Search Alerts/Recalls
|
|
|