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 03/31/2015

Event Type  malfunction  

Event Description

This complaint is reportable based on analysis completed on (b)(4) 2015.It was reported that the anchors protruded through the delivery catheter.The patient was undergoing a left atrial appendage (laa) closure procedure.A 33mm watchman delivery system was selected.The wds was deployed in the laa, but was then recaptured.The device was noted to be fully contained and the recapture was successful.Outside of the patient it was observed that the anchors were protruding from the delivery system catheter, therefore the physician exchanged the device for another of the same to complete the procedure.There were no patient complications reported and the patient was stable.However, device analysis revealed a shaft kink.

Manufacturer Narrative

Patient age at the time of event: over 18 years old.(b)(4).Device evaluated by mfr: returned product consisted of a watchman delivery system (wds).The implant was received in the lumen of the wds attached to the core wire.The shaft was kinked 3mm from the hub.There were scratches in the lumen of the wds near the tip.One of the tri-cut sections of the tip was collapsed in the lumen.There were two anchors on the implant that protruding through the shaft.The confirmed tip damage, scratches in the lumen and anchor damage are consistent with recapturing the implant.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).

• 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: 4803413
• MDR Text Key: 16880743
• Report Number: 2134265-2015-03756
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2017
• Device Model Number: M635WC33060
• Device Catalogue Number: WC33060
• Device Lot Number: 17041893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2014
• 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