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

Model Number M635TU20060

Device Problems Air Leak (1008); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the returned product consisted of the watchman access sheath (was).The device was bloody inside and outside.The valve, hub, sheath, and tip were microscopically, tactile and visually inspected.The inspection of the threads of the was revealed they were damaged/cross threaded.It could not be determined when the thread damage occurred.Inspection of the inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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.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

Same case as mdr id: 2134265-2017-10015 and 2134265-2017-09776.It was reported a hemostasis valve leak occurred.A left atrial appendage (laa) procedure was being performed.A watchman® access system (was) was used.The was had just been placed in the patient when they noticed saline leaking from the hemostasis valve and it was unable to close.They decided not to use that was and removed it from the patient.They replaced it with another was and the procedure continued.They used a 24mm watchman® laa closure device and delivery system.The closure device was deployed and released.The procedure was completed at 11:15; however, the patient coded and became hypotensive at 11:18.They stabilized the patient and moved them to the intensive care unit.Later that day, the patient coded again.They took the patient to the catheterization lab to do a coronary study and the patient was found to have a 90% occlusion of the right coronary artery.The patient's family decided to make the patient "do not resuscitate" after that and then the patient eventually passed away that same day.The cause of death is unknown.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that a significant amount of air was aspirated from the initial access system with the hemostasis valve issue.Prior to assessing the release criteria for device, the patient went into cardiogenic shock with severe hypotension.The transesophageal echocardiogram (tee) probe was emergently removed to help with resuscitation efforts.Transthoracic images obtained after patient went into cardiac arrest revealed severe left ventricle global dysfunction and no pericardial effusion.Resuscitation efforts began with pharmacologic agents (bicarbonate, epinephrine, atropine) initially with no response, and cardiopulmonary resuscitation (cpr) was initiated and the patient was intubated by the anesthesia department.Further resuscitation efforts improved the patient's hemodynamic status and at the termination of the procedure he had a stable blood pressure and pulse and cardiac rhythm were restored.The closure device had been released prior to the episode of hypotension and fluoroscopy at the termination of resuscitation efforts revealed the device to still be in stable position with no evidence of embolization of the device.The decision was made to transport the patient to the ccu for further monitoring.While in ccu the patient developed further hemodynamic decline and was taken to the cardiac cath lab.The patient was encephalopathic.He underwent primary stenting of what appeared to be chronic severe stenosis of the saphenous vein graft to the right.For hemodynamic support an intra-aortic balloon pump and a non-bsc ventricular support device were placed and the patient returned to the ccu with adequate vital signs.There he was stable for a brief period of time but then again developed hemodynamic decline despite efforts with support with intravenous pressors.

• Brand Name: WATCHMAN® ACCESS SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6940387
• MDR Text Key: 90157468
• Report Number: 2134265-2017-09775
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2020
• Device Model Number: M635TU20060
• Device Catalogue Number: TU2006
• Device Lot Number: 0020480586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2017
• 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
• Patient Age: 86 YR
• Patient Weight: 81