MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

Model Number 39467-150

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

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 01/18/2024

Event Type  Injury  

Event Description

It was reported that the st elevation increased.A 1.75mm rotapro and 1.5mm burr were selected for use.Following use of the 1.5mm burr, the st elevation had increased and it was thought that the 1.5mm burr was the cause of the st evaluation since it occurred after the previous use of 1.5 mm burr, so the use was discontinued.The procedure was completed with a different device.There were no further patient complications reported.

Event Description

It was reported that the st elevation increased.A 1.75mm rotapro and 1.5mm burr were selected for use.Following use of the 1.5mm burr, the st elevation had increased and it was thought that the 1.5mm burr was the cause of the st evaluation since it occurred after the previous use of 1.5 mm burr, so the use was discontinued.The procedure was completed with a different device.There were no further patient complications reported.It was further reported that shavings on the 1.5mm burr were probably blown away.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; 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: 18725595
• MDR Text Key: 335613859
• Report Number: 2124215-2024-09039
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0032036411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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): Other