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

Model Number M635TU20060

Device Problem Failure to Advance (2524)

Patient Problem Pericardial Effusion (3271)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.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 mfr: 2134265-2016-00687 and 2134265-2016-00787.It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was performed.A watchman access system (was) was deep seated in the laa.A 24mm watchman laa closure device and delivery system (wds) was inserted; however the device was unable to advance through the was and was therefore removed.A 30 mm watchman laa closure device and delivery system was advanced and deployed.A recapture was performed; but the closure device was able to be implanted successfully.The patient developed a small pericardial effusion which may have occurred after device recapture, but the exact timing of the effusion could not be determined.The patient was hemodynamically stable and therefore was monitored with no additional intervention performed.The patient was doing well post procedure.

• 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: 5444472
• MDR Text Key: 38463710
• Report Number: 2134265-2016-00786
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: M635TU20060
• Device Catalogue Number: TU2006
• Device Lot Number: 18467194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR