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

Model Number M635WC27060

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a hemostasis valve leak occurred.During preparation for a left atrial appendage (laa) closure procedure a 27mm watchman laa closure device & delivery system was selected.However, the physician found that while flushing the system we was unable to remove all the air, the device was leaking fluid and the hemostasis valve could not be fully tightened.The procedure was completed with another of the same device.No patient complication were reported and the patient status is stable.

Manufacturer Narrative

Device evaluated by manufacturer: examination of the returned complaint device revealed that product return consisted of the watchman delivery system (wds).The hub, shaft, tip, core wire, and implant were examined.The implant was in the lumen of the wds.Water was injected into the wds by attaching a syringe filled with water.There were no leaks or air bubbles observed during water injection.The implant was confirmed to be the correct size.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.Bsc id: (b)(4).Tw#: (b)(4).

Event Description

It was reported that a hemostasis valve leak occurred.During preparation for a left atrial appendage (laa) closure procedure a 27mm watchman ® laa closure device & delivery system was selected.However, the physician found that while flushing the system we was unable to remove all the air, the device was leaking fluid and the hemostasis valve could not be fully tightened.The procedure was completed with another of the same device.No patient complication were reported and the patient status is stable.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6680685
• MDR Text Key: 78818815
• Report Number: 2134265-2017-06734
• 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: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: M635WC27060
• Device Catalogue Number: WC27060
• Device Lot Number: 20335693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• 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