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

Model Number	39467-150
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr got stuck with the wire.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left main trunk up to proximal to distal left anterior descending artery.A 2.75mm x 20mm emerge balloon catheter was advanced for dilation.However, during the second inflation for 10 seconds, the balloon ruptured.The device was removed, and another 3.25mm x 15mm nc emerge balloon catheter was advanced for dilatation still, during the second inflation for 10 seconds, the balloon ruptured.The device was also removed, and a new 3.50mm x 15mm nc emerge balloon catheter was advanced but, during the second inflation for 10 seconds, the balloon also ruptured.The device was removed without any problem.A different device was used to complete the dilatation processed.During the same procedure, a 1.50mm rotapro and rotawire was selected for use.The rotation speed during insertion was set at 190,000 rpm and the maximum speed was also at 190,000 rpm.However, the burr got stuck with the wire and could not be released.The rotapro burr and the rotawire were removed as one unit outside the patient.Then, a second rotapro was used to ablate the lesion, and a non-boston scientific balloon catheter was used to expand the lesion and the stent was placed.No patient complications nor injuries were reported, and the patient condition was good post procedure.

• Brand Name: ROTAPRO
• Common Device Name: 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: 20384172
• Report Number: 2124215-2024-59677
• Device Sequence Number: 6465309
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2026
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0033892050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/07/2024
• Date Device Manufactured: 04/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown