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

Model Number	3243
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rotapro burr became stuck on the rotawire.The 99% stenosed target lesion was located in the severely tortuous and severely calcified circumflex artery (cx).A 2.00mm rotapro catheter and a rotawire were selected for a percutaneous coronary intervention (pci) procedure.The rotapro was prepped and platformed at 180,000rpm outside the patient.Then, the burr advanced over the wire, and dynaglide mode used when the catheter was advanced into the lesion.After total of eight ablations were performed successfully, the burr became stuck on the rotawire.The rotapro and the rotawire were removed together as one unit from the patient with a guidezilla guide extension catheter support.The procedure completed successfully with another device.There were no patient complications reported.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12167306
• Report Number: 2134265-2021-08980
• Device Sequence Number: 11759496
• Product Code: MCX
• UDI-Device Identifier: 08714729893387
• UDI-Public: 08714729893387
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

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: 05/27/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0025539623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1