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 No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a hemostasis valve could not be tightened.A left atrial appendage (laa) closure procedure was performed.A watchman® access system was positioned in the laa, the dilator and the unspecified guide wire were removed.However the physician found that the hemostasis valve could not be tightened completely.The patient experienced only a little blood loss which did not require an intervention.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is stable.

Manufacturer Narrative

Device evaluated by manufacturer: examination of the returned complaint device revealed that the returned product consisted of the watchman access sheath (was).The valve was opened as received and blood was on the device.The valve, hub, shaft, and tip were examined.There were multiple kinks found along the shaft of the device.The tip was damaged with shaft material folded back onto the device.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 that a hemostasis valve could not be tightened.A left atrial appendage (laa) closure procedure was performed.A watchman access system was positioned in the laa, the dilator and the unspecified guide wire were removed.However the physician found that the hemostasis valve could not be tightened completely.The patient experienced only a little blood loss which did not require an intervention.The procedure was completed with another of the same device.No patient complications were reported and the patient's status 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6614872
• MDR Text Key: 76764746
• Report Number: 2134265-2017-05946
• 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: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: M635TC20060
• Device Catalogue Number: TC20060
• Device Lot Number: 19617261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2016
• 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: 76 YR