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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that the burr got stuck on the rotawire.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A rotablator and a rotawire and wireclip torquer were selected for use.Set rotational speed was 180,000 rpm with the maximum speed at 180,000 rpm.During removal, it was noted that the rotaburr got stuck on the rotawire.Both rotablator and a rotawire were removed together from the patient body and the procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by manufacturer: the returned device was received.The guidewire had the spring tip bent/kink.Also, the device is kinked at 12 inches from the distal end.Dimensional inspection was performed.The device was measured within specification.
Event or Problem Description
It was reported that the burr got stuck on the rotawire.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A rotablator and a rotawire and wireclip torquer were selected for use.Set rotational speed was 180,000rpm with the maximum speed at 180,000 rpm.During removal, it was noted that the rotaburr got stuck on the rotawire.Both rotablator and a rotawire were removed together from the patient body and the procedure was completed with another of same device.No patient complications were reported.The device was returned for analysis and evaluation was completed on 15dec2021.Visual inspection revealed that the returned guidewire had the spring tip bent/kink.Also, the device is kinked at 12" from the distal end.Microscopic inspection revealed that the returned guidewire had the spring tip bent/kink.Dimensional inspection revealed that the components were within specifications.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnshon ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12751836
• Report Number: 2134265-2021-13884
• Device Sequence Number: 1453933
• Product Code: MCX
• UDI-Device Identifier: 08714729144168
• UDI-Public: 08714729144168
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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: 02/24/2023
• Device Model Number: 3560
• Device Catalogue Number: 3560
• Device Lot Number: 0026866936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2021
• 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