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

Model Number M635TU40060

Device Problems Contamination /Decontamination Problem (2895); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.Returned product consisted of the watchman access sheath (was) in the box and pouch packaging.The tear tab seal on the box was torn and taped down with scotch tape which was also torn as received.The box had multiple dents and creases.The was inside the pouch as received and a portion of the pouch was opened and separated from the rest of the pouch.Both the was and dilator were on the card and there was no evidence the device was removed from the card.No damage was noted on the was itself or the dilator.Inspection of the remainder of the device, apart from the observed packaging damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported there was difficulty opening the pouch and the device became unsterile.During preparation for a left atrial appendage (laa) closure procedure a watchman access system was selected.However, while trying to open the sterile pouch containing the device, it ripped and was not able to be opened along the seal.It was not introduced into the patient as it had become unsterile.

• 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: 6198852
• MDR Text Key: 63108101
• Report Number: 2134265-2016-12183
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: (01)08714729838210(17)20181031(10)0018573062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2016

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: 10/31/2018
• Device Model Number: M635TU40060
• Device Catalogue Number: TU4006
• Device Lot Number: 0018573062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1