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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WATCHMAN® ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
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BOSTON SCIENTIFIC - GALWAY WATCHMAN® ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL Back to Search Results
Model Number M635TS20060
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/05/2017
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.A watchman® access system was successfully prepared for use.The transseptal 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 250 ml of blood lost.They attempted to unscrew and close the valve four 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.
 
Manufacturer Narrative
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.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).
 
Event Description
It was reported a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman® access system was successfully prepared for use.The transseptal 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 250 ml of blood lost.They attempted to unscrew and close the valve four 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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Brand Name
WATCHMAN® ACCESS SYSTEM
Type of Device
SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6583881
MDR Text Key75719826
Report Number2134265-2017-05042
Device Sequence Number1
Product Code NGV
Combination Product (y/n)N
PMA/PMN Number
P130013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/03/2020
Device Model NumberM635TS20060
Device Catalogue NumberTS-2006
Device Lot Number20116814
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age87 YR
Patient Weight82
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