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

Model Number 3243

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Output Problem (3005)

Patient Problems Perforation of Vessels (2135); Cardiac Tamponade (2226); Foreign Body In Patient (2687)

Event Date 02/25/2021

Event Type  Injury  

Event Description

It was reported that the burr became stuck on the wire, the burr fractured the wire, the drive shaft broke, and a vessel perforation occurred.A 1.25mm rotapro and rotawire and wireclip torquer were selected for use in a percutaneous transluminal coronary rotational atherectomy (ptcra) procedure.The target lesion was approximately 75% calcified and located in moderately tortuous anatomy.During the procedure, while in the ramus circumflex artery (rcx), the burr temporarily failed at the intended high rotation speed and was unable to rotate again.The burr was stuck on the wire and could only be withdrawn approximately 5cm into the guide catheter.Once in the guide catheter, it was able to rotate again at high speeds.The burr then fractured the wire and went straight out of the main trunk causing a perforation.The rotapro drive shaft broke, so only the shaft was able to be pulled out.The patient experienced rapid tamponade, which resulted in pericardial drainage.The perforation was not stabilized by a main stem balloon.Therefore, the perforation was treated by implanting a covered stent from the ramus interventricularis anterior (riva) to the main stem ostium.The burr was jailed and occluded the rcx and ramus intermedius.The patient was stable when moved to the operating room.A piece of the device was removed.Surgery was noted to be successful.The patient was fine post procedure.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11499298
• MDR Text Key: 240297812
• Report Number: 2134265-2021-03233
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 08714729893356
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2021

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 Expiration Date: 12/02/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0026453035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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 Age: 79 YR