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

Model Number	3243
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr likely contributed to the guidewire fracture.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified proximal left anterior descending (lad) artery.A 1.75mm rotapro and a rotawire and wireclip torquer were selected for a percutaneous coronary intervention.A non-boston scientific guidewire was advanced through the lesion in the lad and into the distal lad.The non-boston scientific guidewire was exchanged to a rotawire using a non-boston scientific microcatheter.The 1.75mm rotapro was advanced over the rotawire and rotablation was performed on the proximal lad.The physician then decided to rotablate distally in the mid lad but with a smaller 1.5mm burr.The 1.75mm rotapro was withdrawn over the rotawire using dynaglide.A large kink was noted in the proximal end of the wire.During removal of the rotawire, a fracture occurred.An opticross catheter visualized that approximately 2cm of the guidewire tip remained entirely in the small septal artery and as such could not be snared.The remaining rotawire was withdrawn.The procedure was continued with a new rotawire and a 1.5mm rotablator.Rotablation was performed in the mid lad region with success.The 1.5mm rotablator was withdrawn and the lad was stented with a des stent and post dilated.The patient fully recovered.

• 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: 11790280
• Report Number: 2134265-2021-05884
• Device Sequence Number: 19820664
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0026107269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/07/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: BMW; MICROCATHETER: FINECROSS
• Outcome Attributed to Adverse Event: Required Intervention