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

Model Number M635TS20060

Device Problem Leak/Splash (1354)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 03/08/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-03811.It was reported that a hemostasis valve leak and death occurred.A left atrial appendage (laa) closure procedure was performed.A watchman® access system and a pigtail catheter were positioned in the laa.The implantation was described as challenging.The hemostasis valve could not be closed.Blood loss/leakage of one and half liters or more (ha to 6 gr) occurred despite numerous handlings.The access system was exchanged for a second access system after about an hour.However, the same issue occurred and the hemostasis valve could not be closed on the second access system.There was less blood loss.The patient needed a blood transfusion and treatment with a vaso active agent.The patient was in reanimation with a very serious problem.The patient was in the intensive care unit and in critical condition.Approx 6 days post procedure, the patient expired.The cause of death is not known.

• 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: 6461819
• MDR Text Key: 71824110
• Report Number: 2134265-2017-02512
• 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
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2019
• Device Model Number: M635TS20060
• Device Catalogue Number: TS-2006
• Device Lot Number: 20031300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• 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 Outcome(s): Death
• Patient Age: 78 YR