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

Model Number	3243
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck on the guidewire.A coronary angioplasty was being performed using a rotapro 1.50mm and rotawire for treatment.While using dynaglide mode to remove the device, it was noted that the rotapro burr was stuck on the rotawire and could not move anymore.Both devices were removed together, and the procedure was completed successfully using an alternate method.No patient complications were reported due to this event.
Additional Manufacturer Narrative
B3: used the bsc aware date as the date of event as the date of event is unknown.
Event or Problem Description
It was reported that the burr became stuck on the guidewire.A coronary angioplasty was being performed using a rotapro 1.50mm and rotawire for treatment.While using dynaglide mode to remove the device, it was noted that the rotapro burr was stuck on the rotawire and could not move anymore.Both devices were removed together, and the procedure was completed successfully using an alternate method.No patient complications were reported due to this event.
Additional Manufacturer Narrative
B3: used the bsc aware date as the date of event as the date of event is unknown.Investigation of device by mfr: the returned product consisted of the rotapro atherectomy system.The advancer, drive shaft, and handshake connection were visually examined.Inspection of the device did not identify any damages or defects.Functional testing was performed with the returned rotawire.During functional testing, the returned rotawire was able to be removed with resistance, but was not able to be reinserted into the rotapro device due to a kink in the rotawire.In order to determine the functionality of the rotapro device, a test rotawire was used.During analysis, the test rotawire was able to be fully inserted and removed from the returned rotapro device with no resistance or issues.As the guide catheter used in the procedure was not returned, a test 6f guide catheter was used for testing.During testing, the burr catheter was able to be fully inserted and removed from the test guide catheter with no resistance or issues.Product analysis confirmed the reported stuck wire, as the returned rotawire was kinked and could not be reinserted into the returned rotapro device.The reported resistance with the guide catheter was not able to be confirmed, as the returned burr catheter was able to be fully inserted and removed from the returned rotapro device with no resistance or issues.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17138733
• Report Number: 2124215-2023-30570
• Device Sequence Number: 3941389
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 08/09/2024
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0029930844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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