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

Model Number 39467-125

Device Problem Output Problem (3005)

Patient Problem Perforation (2001)

Event Date 10/07/2023

Event Type  Injury  

Event Description

It was reported that perforation occurred.The 50% stenosed target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery (rca).A 1.25mm rotapro burr was selected for percutaneous coronary intervention (pci) procedure.During the procedure, the device was moved to the distal part of the rca in dynaglide mode.However, the rotation speed became 130,000 rpm and perforation was noted.The device was pulled out and the patient was treated with a covered stent.No further complications were reported.

Event Description

It was reported that perforation occurred.The 50% stenosed target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery (rca).A 1.25mm rotapro burr was selected for percutaneous coronary intervention (pci) procedure.During the procedure, the device was moved to the distal part of the rca in dynaglide mode.However, the rotation speed became 130,000 rpm and perforation was noted.The device was pulled out and the patient was treated with a covered stent.No further complications were reported.

Manufacturer Narrative

The returned product consisted of the rotapro atherectomy system.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection presented no damage or irregularities to the device.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated with no issues.The rotapro advancer was then connected to the rotapro control console system.The knob switch (ablation button) turned on when the button was pushed, and the device was able to reach and maintain optimal rpm in both normal and dynaglide modes with no issues or abnormally high speeds.

• 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 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: 18051537
• MDR Text Key: 327125057
• Report Number: 2124215-2023-60479
• 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: 11/29/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0031673524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• 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): Required Intervention