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

Model Number M635TS20060

Device Problems Air Leak (1008); Kinked (1339); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported a hemostasis valve leak occurred and air appeared in the device.The patient was undergoing a left atrial appendage (laa) closure procedure.A watchman® access system was inserted into the patient; however, the hemostasis valve was not sealed which created a leak of blood.A watchman® laa closure device and delivery system was introduced in the access system, but because the valve was closed to stop the leak, the delivery system strongly rubbed and kinked the access system.Then air was noticed in the access system, so the physician aspirated the air and removed both the access system and delivery system from the patient.A new access system was inserted into the patient and the same delivery system was inserted into the access system.The closure device was successfully deployed and there were no patient complications.The patient's condition post procedure 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: 5675070
• MDR Text Key: 45750802
• Report Number: 2134265-2016-04445
• 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: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• 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: 18736045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2016
• 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: 73 YR