MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number M635WC33060

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: examination of the returned complaint device revealed that there were numerous kinks throughout the shaft of the wds.The outer shaft was damaged by anchors of the implant protruding through the shaft wall.The inner shaft was damaged from the anchors scratching the inner shaft as it was pulled back.A microscopic examination revealed the core wire was wavy near the distal end and that the core wire was detached from the implant.A microscopic examination revealed damage to the tip.The implant was received in the inside of the device when received.Blood was on the implant and three (3) anchors were visibly protruding through the shaft wall.The implant was not able to be deployed during device analysis.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 most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on analysis completed on 21apr2016.A left atrial appendage (laa) closure procedure was being performed.A 33mm watchman laa closure device was deployed in the laa and then fully recaptured for an unspecified reason.Upon removal, it was noted that the closure device punctured the delivery sheath, so that it could not be re-used.The device had been fully contained in the watchman access system during removal.The procedure was completed with a different device.No patient complications were reported and that the patient's status is stable.However, device analysis revealed kinks in the delivery system.

• Brand Name: WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY 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: 5666271
• MDR Text Key: 45492458
• Report Number: 2134265-2016-04344
• 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
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2017
• Device Model Number: M635WC33060
• Device Catalogue Number: WC33060
• Device Lot Number: 17112228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1