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

Model Number	29711
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire became separated.The 50-70% target lesion was located in the mildly - non torutous and moderately calcified tibial artery.A peripheral rotawire and wireclip torquer was selected for use.During the procedure, it was noted that the.014 portion of the wire became separated from.009 portion.The wire and tip were removed intact through rubicon catheter and no portion of the wire embolized to the patient.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that the wire became separated.The 50-70% target lesion was located in the mildly - non torutous and moderately calcified tibial artery.A peripheral rotawire and wireclip torquer was selected for use.During the procedure, it was noted that the.014 portion of the wire became separated from.009 portion.The wire and tip were removed intact through rubicon catheter and no portion of the wire embolized to the patient.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the returned guidewire had the spring tip bent/kink and stretched.Microscopic inspection revealed that after a high magnification inspection, it was found that the spring tip was bent/kink and stretched.Also, a portion of 0.08 inch was not returned.Dimensional inspection of the device that could be measured were performed and revealed that the outer diameter (od) of the distal, medium and proximal section of the device were within specification.However, the overall length was inconclusive.

• Brand Name: PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12745438
• Report Number: 2134265-2021-13818
• Device Sequence Number: 4480170
• Product Code: MCW
• UDI-Device Identifier: 08714729863649
• UDI-Public: 08714729863649
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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: 07/05/2023
• Device Model Number: 29711
• Device Catalogue Number: 29711
• Device Lot Number: 0027608706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Race: White