MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPULSE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 10373

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 02/27/2019

Event Type  Injury  

Event Description

It was reported that a pericardial effusion occurred.A watchman access system (was) double curve was selected for use during a left atrial appendage (laa) closure procedure.After the was and unknown pigtail catheter were positioned, contrast was injected and a pericardial effusion and perforation were noted.At this time, the implanting physician selected a watchman laa closure device and delivery system and deployed the closure device while a second physician simultaneously performed a pericardiocentesis.Approximately 100ccs of blood was drained.Patient had a small decrease in blood pressure without signs of tamponade.After the device was released the was withdrawn to the right atrium and protamine was given.At the end of the case, patient was taken to the intensive care unit.The patient was discharged the next morning post-implant without issues.Upon review of the videos, implanter noted the tip of the pigtail appeared to be in a small pocket with the pigtail portion not fully out of the was.It is likely that the pigtail also pushed forward during advancing the was in the laa causing the perforation.

Event Description

It was reported that a pericardial effusion occurred.A watchman access system (was) double curve was selected for use during a left atrial appendage (laa) closure procedure.After the was and unknown pigtail catheter were positioned, contrast was injected and a pericardial effusion and perforation were noted.At this time, the implanting physician selected a watchman laa closure device and delivery system and deployed the closure device while a second physician simultaneously performed a pericardiocentesis.Approximately 100ccs of blood was drained.Patient had a small decrease in blood pressure without signs of tamponade.After the device was released the was was withdrawn to the right atrium and protamine was given.At the end of the case, patient was taken to the intensive care unit.The patient was discharged the next morning post-implant without issues.Upon review of the videos, implanter noted the tip of the pigtail appeared to be in a small pocket with the pigtail portion not fully out of the was.It is likely that the pigtail also pushed forward during advancing the was in the laa causing the perforation.It was further reported that the pigtail catheter was a 5 fr bsc pigtail.

Manufacturer Narrative

Correction made to field with updated device information.

• Brand Name: IMPULSE
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8451761
• MDR Text Key: 139839615
• Report Number: 2134265-2019-02621
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0022882582
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR