MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number UNK130

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

Patient Problems Death (1802); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 06/11/2018

Event Type  Death  

Manufacturer Narrative

Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mfr: 2134265-2018-05841 & 2134265-2018-06240 & 2134265-2018-05900.It was reported that a perforation resulting in tamponade occurred and the patient expired.A left atrial appendage (laa) closure procedure was being performed.A double curved watchman® access system (was) along with a 6fr expo pigtail catheter were used to gain access into the appendage.A 24mmwatchman ® laa closure device & delivery system was then inserted.The markers were lined up and they snapped the sheath back on to the delivery catheter, during this process the delivery system had exited the distal end of the was.They took a little puff of contrast before they deployed the closure device and noticed contrast in the pericardium, indicating a perforation had occurred.The perforation happened at some point between the physician withdrawing the expo pigtail out of the body and snapping the wds into the was.The 24mm closure device was deployed.The perforation led to a pericardial effusion with tamponade.A tap procedure was performed to drain the blood, every time they removed 6cc syringe of blood they would just put it back in the groin, that was probably completed 20 to 25 times.Epinephrine and vasopressor medication were administered.The patient stabilized and was doing okay, so they partially recaptured the closure device few millimeters and redeployed the device.It was shown on echocardiogram that the device was too proximal, so the closure device was fully recaptured.Another 24mmwatchman ® laa closure device was deployed, but they could not position the device appropriately in the appendage, so the closure device was removed.A cardiac surgeon was consulted and the patient was taken to the operating room (or) where they performed a maize procedure.The patient did fine in surgery and was transferred to the cardiac intensive care unit.In the middle of the night or morning the patient experienced tamponade again.They were brought back to the operating room (or) for a pericardiocentesis.The patient left the operating room (or) on vasopressors and four chest tubes.They thought the patient was experiencing volume overload and needed diuretics.They coded and cardiopulmonary resuscitation (cpr) was performed.The patient was pronounced dead 10 minutes later.The documented cause of death was cardiac vasoplegia.

• Brand Name: EXPO GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7665197
• MDR Text Key: 113272633
• Report Number: 2134265-2018-06590
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992142
• 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: 06/11/2018

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 Model Number: UNK130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death; Required Intervention
• Patient Age: 62 YR