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

Model Number M635TS10060

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of the watchman access sheath (was) with dilator inside the sheath as received.The valve was opened as received and blood was on the device.The valve, hub, shaft, and tip were microscopically and tactile inspected.Inspection revealed numerous kinks in the sheath, with the threads of the was were damaged/cross threaded.It could not be determined when the thread damage occurred.Inspection of the 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 reported a valve leak occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman® access system (was) was used.During the procedure, the hemostasis valve was found to be leaking blood after the valve was fully closed.The patient experienced a drop in hemoglobin.The valve was tightened onto the dilator and it was turning, but it did form a seal.The leaking was attempted to be stopped by thumb pressure, but it was not sufficient.The procedure was completed with this access system.The patient¿s condition was stable.

Manufacturer Narrative

(b)(4).

Event Description

It was initially reported that the valve was tightened onto the dilator and it was turning, but it did form a seal.It was further clarified that the valve was not tightened onto the dilator.It was turning, but it did not form a seal.

• 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 Key: 6882127
• MDR Text Key: 86984329
• Report Number: 2134265-2017-09194
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: RO
• 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: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Model Number: M635TS10060
• Device Catalogue Number: TS-1006
• Device Lot Number: 19881226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2016
• 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
• Patient Age: 79 YR
• Patient Weight: 80