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 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that they were unable to tighten the hemostasis valve.A left atrial appendage (laa) closure procedure was performed.A watchman® access system was positioned in the laa.The hemostasis valve could not be tightened completely after the dilator and guide wire were removed.The procedure was completed with another of the same device.The patient was stable.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: the returned product consisted of the watchman access sheath (was).The valve was opened as received and blood inside and outside of the device.The valve, hub, shaft, and tip were microscopically and tactile inspected.Inspection of the threads of the was revealed damaged (cross threaded).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 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 further reported that the valve leaked at most 50ml of blood.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6912122
• MDR Text Key: 88158319
• Report Number: 2134265-2017-10067
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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
• Type of Report: Initial,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: M635TC20060
• Device Catalogue Number: TC20060
• Device Lot Number: 19745030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1