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

Model Number	3560
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr and rotawire ruptured.A 1.50mm rotablator rotalink plus and rotawire was selected for use.During the procedure, it was noted that both rotablator burr and rotawire ruptured together.The procedure was completed with a different device.No complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
D4: lot number: 0028670581.D4: unique identifier (udi) #: (b)(4).Device evaluated by mfr.: the device was returned for analysis.The proximal end and wire body were visually and microscopically examined.Inspection of the device found that the wire was fractured at the distal end.The damage to the wire was inspected and was found to most closely resemble a wear fracture.
Event or Problem Description
It was reported that the burr and rotawire ruptured.A 1.50mm rotablator rotalink plus and rotawire was selected for use.During the procedure, it was noted that both rotablator burr and rotawire ruptured together.The procedure was completed with a different device.No complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that the burr and rotawire ruptured.A 1.50mm rotablator rotalink plus and rotawire was selected for use.During the procedure, it was noted that both rotablator burr and rotawire ruptured together.The procedure was completed with a different device.No complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The proximal end and wire body were visually and microscopically examined.Inspection of the device found that the wire was fractured at the distal end.The damage to the wire was inspected and was found to most closely resemble a wear fracture.

• 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 DE COSTA RICA S.R.L.; 302 parkway, global park; global park, la aurora; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16397816
• Report Number: 2124215-2023-05759
• Device Sequence Number: 12370470
• Product Code: MCX
• UDI-Device Identifier: 08714729144168
• UDI-Public: 08714729144168
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2023

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: 01/12/2024
• Device Model Number: 3560
• Device Catalogue Number: 3560
• Device Lot Number: 0028670581
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 10/26/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 07/14/2023; 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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