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

Model Number M635TC20060

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was being performed.The watchman ® access system was being advanced over the guidewire into the la.It was noticed that the hemostasis valve was leaking blood.The leak continued when the 6f pigtail catheter was inserted.The hemostasis valve was not too tight and the physician attempted to close the valve to stop the leaking, but was unsuccessful and the patient experienced 350 ml of blood loss.The physician introduced an unknown 8f sheath as an auxiliary device to stop the leaking and the procedure was completed successfully.The patient's condition was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the watchman access sheath (was).Blood was on the device and the valve was opened as received.Kinks were found 5cm, 26cm, and 52cm from the tip of the access system.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 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.The reported issue was not confirmed.There was no evidence of any material or manufacturing deficiencies contributing to the reported event.Because there was no evidence of any product quality deficiencies, it was considered likely that the shaft kinks were attributable to procedural factors.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.A left atrial appendage (laa) closure procedure was being performed.The watchman ® access system was being advanced over the guidewire into the la.It was noticed that the hemostasis valve was leaking blood.The leak continued when the 6f pigtail catheter was inserted.The hemostasis valve was not too tight and the physician attempted to close the valve to stop the leaking, but was unsuccessful and the patient experienced 350 ml of blood loss.The physician introduced an unknown 8f sheath as an auxiliary device to stop the leaking and the procedure was completed successfully.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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5920846
• MDR Text Key: 53691728
• Report Number: 2134265-2016-07961
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: M635TC20060
• Device Catalogue Number: TC20060
• Device Lot Number: 18756167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• 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): Required Intervention