MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number	3560
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck on the guidewire.A rotawire guidewire was selected for use and was wiped with a wet compress upon unpacking.The rotawire guidewire and rotapro device were used together during the procedure.During retraction of the devices, the rotapro drill became stuck on the rotawire.The rotawire was removed manually and in dynaglide mode.The rotawire guidewire was removed intact and the procedure was able to be completed with the same rotapro device.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter phone:(b)(6).Device evaluated by manufacturer: the returned product consisted of the rotawire device.Product analysis confirmed the spring tip was bent.During product analysis it was observed that the spring tip was bent.It is important to mention that in the event description specifies that the guidewire was wiped with a wet compress.However, the ifu specifies that "the guidewires are coated with a thin film of lubricant which may appear as a white powder.Do not wipe off lubricious coating.The lubricant can cause the guidewire to adhere to the inside of the tube, making unloading difficult.If this happens, gently tap the outside of the coil to loosen the wire.Use care not to stretch or damage the spring tip." it is possible that because the guidewire was wiped, this may have contributed to the observed damage on the spring tip and consequently to the reported issues.
Event or Problem Description
It was reported that the burr was stuck on the guidewire.A rotawire guidewire was selected for use and was wiped with a wet compress upon unpacking.The rotawire guidewire and rotapro device were used together during the procedure.During retraction of the devices, the rotapro drill became stuck on the rotawire.The rotawire was removed manually and in dynaglide mode.The rotawire guidewire was removed intact and the procedure was able to be completed with the same rotapro device.No patient complications were reported.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17475973
• Report Number: 2124215-2023-41877
• Device Sequence Number: 7347669
• Product Code: MCX
• UDI-Device Identifier: 08714729144168
• UDI-Public: 08714729144168
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: 01/24/2025
• Device Model Number: 3560
• Device Catalogue Number: 3560
• Device Lot Number: 0030922012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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