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

Model Number	29711
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire was fractured and an additional surgery was required.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified posterior tibial artery (pt).A peripheral rotawire and wireclip torquer - bx5 was selected for use and inserted through a bern catheter.During the procedure, the 5fr bern catheter was removed and left-sided 5/6 fr slender sheath access was lost.Upon reinsertion of the pedal sheath over the wire, the rotawire looped, kinked and broke off in the foot.No hematoma or active bleeding was noted.The physician attempted to re-stick the left pt with the ultrasound guidance, but no vessel was visualized and spasm was presumed.Right common femoral artery access was obtained with a 6fr sheath.However, the physician noticed that the rotawire was now located in the descending superior vena cava.A 6fr snare was used in an attempt to remove the device.The rotawire was pulled into the right common iliac artery, but broke in the snare.The intended procedure was not completed.The patient was then transported to a vascular surgeon for removal of the wire.A small incision was made in the top of the left foot and hemostats were used to remove the rotawire in its entirety.No bleeding occurred and the patient fully recovered after the procedure.
Additional Manufacturer Narrative
Correction: h6 device codes: detachment of device or device component.Device evaluated by manufacturer: the device was returned for analysis.Visual & microscopic inspection revealed that the guidewire was observed with a portion detached and not returned, approximately at 10 cm from the distal tip.The device has multiple kinks.Dimensional inspection revealed that the overall length does not meet specifications.The reported complaint was confirmed.
Event or Problem Description
It was reported that the guidewire was fractured and an additional surgery was required.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified posterior tibial artery (pt).A peripheral rotawire and wireclip torquer - bx5 was selected for use and inserted through a bern catheter.During the procedure, the 5fr bern catheter was removed and left-sided 5/6 fr slender sheath access was lost.Upon reinsertion of the pedal sheath over the wire, the rotawire looped, kinked and broke off in the foot.No hematoma or active bleeding was noted.The physician attempted to re-stick the left pt with the ultrasound guidance, but no vessel was visualized and spasm was presumed.Right common femoral artery access was obtained with a 6fr sheath.However, the physician noticed that the rotawire was now located in the descending superior vena cava.A 6fr snare was used in an attempt to remove the device.The rotawire was pulled into the right common iliac artery, but broke in the snare.The intended procedure was not completed.The patient was then transported to a vascular surgeon for removal of the wire.A small incision was made in the top of the left foot and hemostats were used to remove the rotawire in its entirety.No bleeding occurred and the patient fully recovered after the procedure.

• Brand Name: PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
• Common Device Name: CATHETER, PERIPHERAL, 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; la aurora - heredia ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16503731
• Report Number: 2124215-2023-09086
• Device Sequence Number: 11600970
• Product Code: MCW
• UDI-Device Identifier: 08714729838890
• UDI-Public: 08714729838890
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/19/2023

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: 11/06/2024
• Device Model Number: 29711
• Device Catalogue Number: 29711
• Device Lot Number: 0030493509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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: Required Intervention
• Patient Sex: Unknown