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

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

Patient Problems Chest Pain (1776); Perforation (2001); Restenosis (4576)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

E1: (b)(6).

Event Description

It was reported that perforation and chest pain occurred.The stenosed target lesion was located in the middle right coronary artery (rca).A 2.00mm x 15mm fg emerge balloon catheter was advanced for dilation.However, during multiple inflation of the device it resulted in a small perforation in the right coronary artery (rca).The balloon was left reinflated for 10 minutes, then a non-boston scientific device was used to cover the stent and was quickly advanced and inflated.Following stent deployment, a synergy xd stent was placed in the proximal right coronary artery (rca) and post-dilated.The procedure was completed with a different device.The patient experiences some chest pain but never hemodynamically unstable because of the perforation of rotablator atherectomy and balloon dilatation of right coronary artery (rca), post-procedure the patient status was hemodynamically stable.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).H6: patient code: removed restenosis.

Event Description

It was reported that perforation and chest pain occurred.The stenosed target lesion was located in the middle right coronary artery (rca).A 2.00mm x 15mm fg emerge balloon catheter was advanced for dilation.However, during multiple inflation of the device it resulted in a small perforation in the right coronary artery (rca).The balloon was left reinflated for 10 minutes, then a non-boston scientific device was used to cover the stent and was quickly advanced and inflated.Following stent deployment, a synergy xd stent was placed in the proximal right coronary artery (rca) and post-dilated.The procedure was completed with a different device.The patient experiences some chest pain but never hemodynamically unstable because of the perforation of rotablator atherectomy and balloon dilatation of right coronary artery (rca), post-procedure the patient status was hemodynamically stable.

• 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 CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18763561
• MDR Text Key: 336033993
• Report Number: 2124215-2024-10657
• 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,Followup
• Report Date: 03/13/2024

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/13/2024
• 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): Required Intervention
• Patient Sex: Female