MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE WATCHMAN® ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number M635TS20060

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 that a valve leak occurred.The patient was undergoing a left atrial appendage (laa) closure procedure.A watchman access system (was) was positioned in the laa and it was noted that the valve was not completely sealed.The physician closed the valve very tightly to limit the backbleed from the valve.He attempted to introduce a watchman laa closure device & delivery system; however, strong resistance was noted and the was kinked.Both devices were removed and the procedure was completed with new watchman devices.No patient complications were reported and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the watchman access sheath (was).The valve was opened, as received, with blood was on the device.The valve, hub, shaft, and tip were microscopically, tactile and visually inspected.Inspection revealed kinks in the sheath at 4.5cm, 45 cm and 64 cm from the tip, sheath damage (flattened) for 8 cm, tip damage (split), and hub damage (cross threading).Functional testing of the valve confirmed the ability to completely close the valve with forward force.Water was injected into the was by attaching a syringe filled with water.There were no leaks or air bubbles observed during water injection.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 that a valve leak occurred.The patient was undergoing a left atrial appendage (laa) closure procedure.A watchman® access system (was) was positioned in the laa and it was noted that the valve was not completely sealed.The physician closed the valve very tightly to limit the backbleed from the valve.He attempted to introduce a watchman ® laa closure device & delivery system; however, strong resistance was noted and the was kinked.Both devices were removed and the procedure was completed with new watchman devices.No patient complications were reported and the patient's condition was stable.

• Brand Name: WATCHMAN® ACCESS 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: 5643682
• MDR Text Key: 44891425
• Report Number: 2134265-2016-03770
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: M635TS20060
• Device Catalogue Number: TS-2006
• Device Lot Number: 17852728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 91033431-FA
• Patient Sequence Number: 1
• Patient Age: 80 YR