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

Model Number	39467-125
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr got stuck on the guidewire.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 1.25mm rotapro and rotawire were selected for use.During removal, it was noted that the wire got kinked approximately 2cm from the proximal part of the wire.Consequently, the burr got stuck on the guidewire.The burr and rotawire were removed from the body as one unit.The procedure was completed with another of the same device.There were no patient complications reported post procedure.
Event or Problem Description
It was reported that the burr got stuck on the guidewire.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 1.25mm rotapro and rotawire were selected for use.During removal, it was noted that the wire got kinked approximately 2cm from the proximal part of the wire.Consequently, the burr got stuck on the guidewire.The burr and rotawire were removed from the body as one unit.The procedure was completed with another of the same device.There were no patient complications reported post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The device was returned for analysis.Visual and microscopic inspection of the device did not identify any damages or defects.Analysis was performed using the returned rotawire.During testing, the returned wire was removed from the advancer with resistance at the handshake connection.There was a severe kink to the proximal end of the returned rotawire and the most distal portion of the rotawire failed to return as the wire was returned separated and the spring tip was not present.Removal from the burr catheter was completed proximally due to the severe wire kink as resistance was present.Reinsertion of the wire was not completed due to wire damages present.

• 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: 20402173
• Report Number: 2124215-2024-62633
• Device Sequence Number: 3579735
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: 04/27/2025
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0031516896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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