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 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a hemostasis valve leak occurred.The patient was undergoing a left atrial appendage (laa) closure procedure.The watchman® access system was being advanced with the dilator through the femoral vein to the right atrium and then to the left atrium.When the dilator was removed and the hemostasis valve was tightened, blood was leaking.They attempted to re-tighten the valve, but blood continued to leak from the access system.The leaking was controlled by thumb pressure until the end of the procedure.The procedure was completed with this device.No patient complications were reported and the patient's condition is stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the watchman access sheath (was) and dilator.The valve was opened as received.Microscope examination of the valve did not reveal any damage or irregularities; however, it was noted that the threads of the was were damaged/cross threaded.It could not be determined when the thread damage occurred.Functional testing of the valve confirmed the ability to completely close the valve with minimal 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 manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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 a hemostasis valve leak occurred.The patient was undergoing a left atrial appendage (laa) closure procedure.The watchman® access system was being advanced with the dilator through the femoral vein to the right atrium and then to the left atrium.When the dilator was removed and the hemostasis valve was tightened, blood was leaking.They attempted to re-tighten the valve, but blood continued to leak from the access system.The leaking was controlled by thumb pressure until the end of the procedure.The procedure was completed with this device.No patient complications were reported and the patient's condition is 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5635513
• MDR Text Key: 44558472
• Report Number: 2134265-2016-03856
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: M635TS20060
• Device Catalogue Number: TS-2006
• Device Lot Number: 18714075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 05/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2015
• 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: 81 YR