WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM 10365

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-18 for WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM 10365 manufactured by Boston Scientific Corporation.

Event Text Entries

[183921140] It was reported that there was a perforation and a pericardial effusion. A left atrial appendage (laa) closure procedure was being performed. There was no thrombus or pericardial effusion noted at baseline. During the trans-septal puncture, st elevation occurred and air was noted in the laa. Pure oxygen administration was immediately started, and the air bubbles were checked in the laa by tee. The patient's blood pressure decreased, but it was temporary. The rising st also improved. The watchman access system (was) and pig tail catheter were inserted into the patient and blood was suctioned from the side port of was, and the physician tried to remove air bubbles in laa. Some air bubbles slightly remained in the distal end of the laa, but the physician felt there was no problem and continued the procedure with no further st changes. These prior events were not related to the watchman devices. A 30mm watchman laa closure device & delivery system (wds) was chosen. The was was positioned in the laa and the wds was inserted into it. The closure device was deployed twice in the laa and did not meet release criteria. Both times the physician performed a partial recapture. Following the second partial recapture it was noted that there was a perforation and a small pericardial effusion that was present around the laa and around the right ventricle (rv). The procedure continued and the closure device was deployed a third time in the laa of the patient. The closure device met release criteria and was released from the core wire and implanted in the laa. The was and wds were removed from the patient. Protamine was administered, and heparin neutralization was planned. Five minutes later, the patients blood pressure started to decrease. Evaluation by transesophageal echocardiogram (tee) and transthoracic echocardiogram (tte) was continued and there was no change around the laa and 1-2 mm change around the rv. Pericardial drainage was not necessary since the patient's hemodynamics were stable. The patient was transferred to the critical care unit. The patient is doing fine and there were no other complications that were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03383
MDR Report Key9848184
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2020-02-19
Date Mfgr Received2020-02-19
Device Manufacturer Date2019-02-11
Date Added to Maude2020-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
Generic NameSYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Product CodeNGV
Date Received2020-03-18
Model Number10365
Catalog Number10365
Lot Number0023329766
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-18

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