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

Lot Number 0024343544

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

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 12/09/2019

Event Type  Injury  

Event Description

It was reported that a perforation and a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 30mm watchman laa closure device & delivery system (wds) were used.The left atrial appendage (laa) was accessed using a standard transseptal needle system and.035mm wire.An approximate mid-mid access was attained.The.035 wire was advanced towards the upper pulmonary vein.The transseptal system was removed and a watchman truseal access sheath was inserted over the.035 wire into the laa.A 6f impulse pigtail was inserted into the truseal sheath and advanced towards the upper pulmonary vein and the.035 wire was removed.The truseal sheath was then advanced over the 6f pigtail catheter.The pigtail was advanced into the anterior laa.The truseal sheath was torqued to advance to the anterior lobe.The proximal portion (outside of the body) of the truseal sheath was then noted to have a kink and was removed over an.035 wire.The wire was placed into the upper pulmonary vein.A new truseal sheath was inserted over the.035 wire.The 6f pigtail was then inserted over the.035 wire into the left atrium and the.035 wire was removed.The pigtail was then advanced into the anterior lobe of the laa.The access sheath was then advanced over the pigtail catheter to the distal anterior lobe of the laa.A 30mm closure device was prepped and inserted into the truseal sheath.It was noted that the wds met resistance approximately two thirds of the way through the truseal sheath.It was also then noted that the proximal shaft of the wds (outside of the body) was partially kinked.The truseal sheath was imaged under fluoroscopy and no kinks were visible.The wds was then removed.Upon an angiogram with the pigtail still in the laa anterior lobe it was noted that the tip of the pigtail catheter had perforated through the atrial wall and created a pericardial effusion.A pericardiocentesis kit was used to drain approximately 600ml of blood from the patient.The effusion was imaged with transesophageal echocardiogram (tee) during and after treatment this treatment.The effusion did not increase in size.The patient was reported as stable post treatment and there were no other reported issues that occurred.

Manufacturer Narrative

Added patient code of cardiac perforation.Corrected: brand name from watchman truseal access system to impulse common device name from system, appendage closure, left atrial to catheter, intravascular, diagnostic.Pro code (product code) from dqy to dqo.

Event Description

It was reported that a perforation and a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 30mm watchman laa closure device & delivery system (wds) were used.The left atrial appendage (laa) was accessed using a standard transseptal needle system and.035mm wire.An approximate mid-mid access was attained.The.035 wire was advanced towards the upper pulmonary vein.The transseptal system was removed and a watchman truseal access sheath was inserted over the.035 wire into the laa.A 6f impulse pigtail was inserted into the truseal sheath and advanced towards the upper pulmonary vein and the.035 wire was removed.The truseal sheath was then advanced over the 6f pigtail catheter.The pigtail was advanced into the anterior laa.The truseal sheath was torqued to advance to the anterior lobe.The proximal portion (outside of the body) of the truseal sheath was then noted to have a kink and was removed over an.035 wire.The wire was placed into the upper pulmonary vein.A new truseal sheath was inserted over the.035 wire.The 6f pigtail was then inserted over the.035 wire into the left atrium and the.035 wire was removed.The pigtail was then advanced into the anterior lobe of the laa.The access sheath was then advanced over the pigtail catheter to the distal anterior lobe of the laa.A 30mm closure device was prepped and inserted into the truseal sheath.It was noted that the wds met resistance approximately two thirds of the way through the truseal sheath.It was also then noted that the proximal shaft of the wds (outside of the body) was partially kinked.The truseal sheath was imaged under fluoroscopy and no kinks were visible.The wds was then removed.Upon an angiogram with the pigtail still in the laa anterior lobe it was noted that the tip of the pigtail catheter had perforated through the atrial wall and created a pericardial effusion.A pericardiocentesis kit was used to drain approximately 600ml of blood from the patient.The effusion was imaged with transesophageal echocardiogram (tee) during and after treatment this treatment.The effusion did not increase in size.The patient was reported as stable post treatment and there were no other reported issues that occurred.

• 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: 9510457
• MDR Text Key: 173336976
• Report Number: 2134265-2019-16014
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729965718
• UDI-Public: 08714729965718
• Combination Product (y/n): N
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• Device Lot Number: 0024343544
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 01/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention