MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 08/11/2023

Event Type  Injury  

Event Description

It was reported that a perforation occurred requiring surgical intervention and hospitalization.The 90% stenosed target lesion was located in the severely calcified ostial left anterior descending artery and left circumflex artery.A 1.5 rotapro was selected for rotablator atherectomy of left main coronary artery.During the procedure, the lad atherectomy was performed without any issue.However, after several rotablator runs, it was noted that there was a perforation at the left circumflex artery and the left main coronary artery.The ostial left circumflex artery plaque was located on a 90-degree bend off the left main coronary artery, and this may have led to the burr moving outside the true lumen and causing the perforation.The physician then utilized a non-boston scientific covered stents to try to close the perforation in the lcx and lm arteries.Consequently, the patient was brought to the operating room for immediate coronary artery bypass graft (cabg) surgery as the perforation could not be contained.The rotaburr was dynaglided out with no problems at all and the procedure was completed using an alternate method.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17764994
• MDR Text Key: 323616231
• Report Number: 2124215-2023-49114
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/18/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 82 YR
• Patient Sex: Male