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

Model Number M635WS33060

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the watchman delivery systems (wds).There was blood in the shaft.There were numerous kinks at the distal end of the shaft.There was no damage to the braiding.The implant was received inside the shaft of the device, which matches the reported event.The implant was deployed and the anchors were inspected.There were bent and damaged anchors.The core wire was twisted from the end of the implant proximal 4cm and kinked 3.5cm from the implant.The tip was folded and damaged.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.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 (b)(6) 2015.It was reported that partial deployment occurred.A left atrial appendage (laa) closure procedure was performed.The watchman access system was positioned in the laa and a 33mm watchman closure device prepared.During preparation, the watchman¿ closure device was retracted 5cm within the delivery system and advanced forward to the markerband.The watchman closure device was advanced through the watchman access system and deployed.Fluoroscopy showed that only 2/3 of the watchman closure device came out of the watchman access system.The physician could not deploy the device any further.The watchman closure device was fully recaptured and removed.Imaging showed that the core wire was twisted which is likely why the watchman closure device could not be deployed completely.The procedure was successfully completed with a second watchman closure device.There were no patient complications reported and the patient is stable post procedure.However, the returned device analysis revealed kinks in the watchman¿ 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: 5188991
• MDR Text Key: 29876537
• Report Number: 2134265-2015-07465
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: M635WS33060
• Device Catalogue Number: WS-3306
• Device Lot Number: 18205715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• 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: 85 YR