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

Device Problem Entrapment of Device (1212)

Patient Problem Vascular Dissection (3160)

Event Date 01/19/2024

Event Type  Injury  

Event Description

It was reported that a device entrapment and dissection occurred.The target lesion was located in the anterior tibial artery.A rotapro 1.75mm and rotawire were selected for use.During the procedure, the rotapro was advanced to the distal anterior tibial artery.The rotation started with periods of rotational deceleration.The device never stalled, however the burr stopped rotating and it could not be moved.Retraction of the device was attempted, but the burr was not able to move.The rotapro burr broke off the catheter and was stuck on the rotawire while inside the patient's leg which caused a dissection in the dorsalis pedis artery.The rotapro catheter was removed, along with the burr remaining on the rotawire.The procedure was completed with an alternative method.There were no patient complications reported and the patient remained unaffected post procedure.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: 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; heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18650854
• MDR Text Key: 334656668
• Report Number: 2124215-2024-05444
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male