MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7528

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

Patient Problems Death (1802); Perforation of Vessels (2135)

Event Date 11/02/2020

Event Type  Death  

Event Description

It was reported that a death occurred.A percutaneous coronary intervention was being performed on a chronic totally occluded lesion in the left main and left anterior descending (lad) coronary artery.A number of products were used during the case including two mamba flex microcatheters, a 20mm x 4.50mm nc quantum apex balloon, a fighter, hornet and judo guidewires, a 2.00mm x 40mm apex balloon, a 20mm x 4.00mm nc quantum apex balloon, a guidezilla ii guide extension catheter, and an opticross imaging catheter.After what seemed to be a successful "investment" procedure, the physician took final shots to confirm there were no perforations or dissections visible, and none were confirmed.An echocardiogram was performed as a precautionary measure and determined there was a minor perfusion around the pericardium.The patient was a previous bypass patient and therefore his pericardium was no longer intact.It was noticed there was a perforation at what seemed to be the anastomosis site of the lima to the lad.A non-boston scientific stent was placed.After the stent was placed it was determined there was still a perforation so a balloon was inflated for 20 minutes in an attempt to prevent tamponade.After this was unsuccessful, another non-boston scientific stent was placed.The bleeding had not yet stopped.Another non-boston scientific stent was placed with no ability to stop the perfusion.The patient began to crash and a pericardiocentesis was completed.After many attempts at trying to get the patient back and to stop the bleeding, coils were delivered as well as thrombin injected.The patient was shocked and given chest compressions until he was finally pronounced dead.

• Brand Name: APEX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10876726
• MDR Text Key: 217428503
• Report Number: 2134265-2020-15655
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860019
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7528
• Device Catalogue Number: 7528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death