MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE WATCHMAN® ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number M635TC20060

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was performed.A watchman access system (was)was selected; however, the hemostasis valve was hard to close.After exchanging the was with an unspecified trans septal sheath a leak was noted.The leak was stopped by applying thumb pressure and finally they introduced an unspecified 8fr short sheath into the valve.Approximately 60ml of blood was lost.The procedure was complete with another of the same devices.No further patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: examination of the returned complaint device revealed that the returned product consisted of the watchman access sheath (was) with an extra was with a dilator in the shaft.There was no damage to the extra was or dilator.There was blood inside and on the shaft.There were numerous kinks throughout the shaft.A microscopic 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.The valve was open when received.An attempt was made to close the valve, and the valve was successfully closed without using forward pressure or without any difficulties.Functional testing was completed by closing the valve and injecting water 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 that a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was performed.A watchman access system (was) was selected; however, the hemostasis valve was hard to close.After exchanging the was with an unspecified trans septal sheath a leak was noted.The leak was stopped by applying thumb pressure and finally they introduced an unspecified 8fr short sheath into the valve.Approximately 60ml of blood was lost.The procedure was complete with another of the same devices.No further patient complications were reported.

• Brand Name: WATCHMAN® ACCESS SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5381490
• MDR Text Key: 36460518
• Report Number: 2134265-2016-00031
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: M635TC20060
• Device Catalogue Number: TC20060
• Device Lot Number: 17708567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 91033431 FA
• Patient Sequence Number: 1