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

Model Number H74908526402

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Thrombosis (2100); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 09/21/2017

Event Type  Death  

Manufacturer Narrative

Device evaluated by manufacturer: visual examination of the returned device revealed no damage.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mfr: 2134265-2017-09919,2134265-2017-09956.It was reported that a perforation with tamponade occurred, resulting in complications and death.A left atrial appendage (laa) closure procedure was being performed.Using an expo guide catheter, the watchman access system (was) was deep seated in the laa.A 24mm watchman laa closure device & delivery system (wds) was advanced and the closure device was deployed.After deployment, a jet flow of contrast medium was noted inside the laa into the pericardium, resulting in blood flow in the pericardium.The perforation of the laa resulted in cardiac tamponade.As they were not able to obtain good views of the closure device¿s placement with transesophageal echocardiogram (tee), they opted to fully recapture the device and begin pericardiocentesis.The patient¿s blood pressure decreased.Approximately 1 liter of blood was aspirated and autologous transfusion of 4 units was administered.Approximately one hour later no additional blood could be aspirated.The patient was treated with double catecholamine therapy, administration of protamine and erythrocyte concentrates.However, an intrapericardial clot had formed and could not be removed with flushing.Asystole occurred and cardiac massage was performed with a cpr machine.After approximately 25 minutes of reanimation, the patient passed away.Per the family, no autopsy will be performed.

• 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 (Section G): AVAIL MEDICAL PRODUCTS INCORPORATED; 5950 nancy ridge drive; san diego CA 92121
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6959190
• MDR Text Key: 89671715
• Report Number: 2134265-2017-10046
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K992142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2017

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: 07/31/2019
• Device Model Number: H74908526402
• Device Catalogue Number: 08526-40
• Device Lot Number: 0060072498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 82 YR