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

Model Number	29710
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was blood-tinged tissue present on the wire.The 100% stenosed target lesion was located in the left superficial femoral artery.A peripheral rotawire guidewire was selected for use.During the procedure, a 2.00mm peripheral rotalink plus system began making a high-pitched noise and the burr seemed to be stuck as the physician attempted to move it slightly back and forth without success.The physician then switched to dynaglide mode to completely remove the burr out of the patient's body and was able to do so.When the rotawire was removed from the patient's body, it was noted that there was blood-tinged tissue present on the wire.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Visual and microscopic inspection revealed that the device has a kink in the body of the guidewire located approximately at 45 cm from the proximal end.Residue was noted stuck in the body of the guidewire.Therefore, the reported event was confirmed.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that there was blood-tinged tissue present on the wire.The 100% stenosed target lesion was located in the left superficial femoral artery.A peripheral rotawire guidewire was selected for use.During the procedure, a 2.00mm peripheral rotalink plus system began making a high-pitched noise and the burr seemed to be stuck as the physician attempted to move it slightly back and forth without success.The physician then switched to dynaglide mode to completely remove the burr out of the patient's body and was able to do so.When the rotawire was removed from the patient's body, it was noted that there was blood-tinged tissue present on the wire.The procedure was completed with another of the same device.No patient complications were reported.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15121456
• Report Number: 2134265-2022-08205
• Device Sequence Number: 5614807
• Product Code: MCW
• UDI-Device Identifier: 08714729863649
• UDI-Public: 08714729863649
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: 29710
• Device Catalogue Number: 29710
• Device Lot Number: 0029094950
• 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: 07/11/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Race: White