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

Model Number M635WU30060

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 02/17/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported the core wire moved freely.A left atrial appendage (laa) closure procedure was being performed.While flushing the 30mm watchman ® laa closure device & delivery system, outside of the patient, the user noted that the core wire moved more freely than it should when the hemostasis valve was closed.The device was not used.The procedure was completed with another of the same device without issue.No patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of a watchman delivery system (wds) and implant.The hemostasis valve was tightened down when received.The core wire was attempted to be moved when the hemostasis valve was closed and tight; however, the core wire would not move.When the device was flexed and brought into a circle, there was still no movement of the core wire.The device was flushed and there were no issues or movement of the core wire.Inspection of the device presented no damage or irregularities.No issues were identified during the product analysis.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.(b)(4).

Event Description

It was reported the core wire moved freely.A left atrial appendage (laa) closure procedure was being performed.While flushing the 30mm watchman ® laa closure device & delivery system, outside of the patient, the user noted that the core wire moved more freely than it should when the hemostasis valve was closed.The device was not used.The procedure was completed with another of the same device without issue.No patient complications reported.

• 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: 5507905
• MDR Text Key: 40589647
• Report Number: 2134265-2016-02444
• Device Sequence Number: 1
• Product Code: NGV
• 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,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2016
• Device Model Number: M635WU30060
• Device Catalogue Number: WU3006
• Device Lot Number: 0016454320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2013
• 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