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 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: 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 is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system was introduced inside the patient.After entering the laa, the dilator was removed and blood was leaking through the hemostasis valve which was unable to close.The physician continued the procedure applying thumb pressure to minimize the leak.Once the delivery system is inserted, the gap is closed and the leaking stops.The procedure was completed with this device.There were no patient complications reported and the patient 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: 5738795
• MDR Text Key: 47844322
• Report Number: 2134265-2016-05393
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• 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: 05/25/2016

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: 01/31/2019
• Device Model Number: M635TS20060
• Device Catalogue Number: TS-2006
• Device Lot Number: 18796232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2016
• 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 Age: 75 YR
• Patient Weight: 130