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 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: over 18 years old.(b)(4).

Event Description

It was reported a hemostasis valve leak occurred.The patient was undergoing a left atrial appendage (laa) closure procedure.It was noticed that the hemostasis valve of the watchman access system was unable to be fully closed; therefore, creating a blood leak where 60-70ml of blood was lost.The physician exchanged the access system in order to complete the procedure.No patient complications were reported and the patient's condition is stable.

Manufacturer Narrative

Returned product consisted of the watchman access sheath (was) and dilator, which was inside the was as recieved.The dilator was removed during product analysis.The valve was opened as received with the dilator inside the was.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.Functional testing of the valve confirmed the ability to completely close the valve with minimal forward force after removing the dilator.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.The patient was undergoing a left atrial appendage (laa) closure procedure.It was noticed that the hemostasis valve of the watchman® access system was unable to be fully closed; therefore, creating a blood leak where 60-70ml of blood was lost.The physician exchanged the access system in order to complete the procedure.No patient complications were reported and the patient's condition is stable.

• 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: 5627354
• MDR Text Key: 44345429
• Report Number: 2134265-2016-04188
• 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: 04/25/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: M635TC20060
• Device Catalogue Number: TC20060
• Device Lot Number: 18298551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 91033431 FA
• Patient Sequence Number: 1