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 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

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

Same case as mdr id: 2134265-2016-03708 and 2134265-2016-03710.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.The hemostasis valve was unable to close; therefore, leaking minor amounts of blood.The physician continued the procedure and upon introducing the access system inside the laa over the pigtail, kinks were noticed on the access system due to tension and counter clockwise rotation.The physician removed this access system and attempted to use a second and third access system.The same valve leak and kinks occurred with the second and third access systems.Therefore, the case was not completed as the anatomy of the laa was extremely difficult to be closed.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

Same case as mdr id: 2134265-2016-03708 and 2134265-2016-03710.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.The hemostasis valve was unable to close; therefore, leaking minor amounts of blood.The physician continued the procedure and upon introducing the access system inside the laa over the pigtail, kinks were noticed on the access system due to tension and counter clockwise rotation.The physician removed this access system and attempted to use a second and third access system.The same valve leak and kinks occurred with the second and third access systems.Therefore, the case was not completed as the anatomy of the laa was extremely difficult to be closed.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: 5644138
• MDR Text Key: 44891739
• Report Number: 2134265-2016-03709
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• 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: 18791871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2016
• 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
• Removal/Correction Number: 91033431 FA
• Patient Sequence Number: 1
• Patient Age: 70 YR