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

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that the wire was fractured.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified anterior tibial vessel.A rotawire was selected to treat the entire length of the vessel.The 2.00mm peripheral rotalink plus made a stall sound when approximately 2-3 inches of the vessel was left to treat.Then, the rotapro catheter was removed but it was noted that the burr was sheared off and remained behind on the guidewire.It was also noted that the rotawire fractured when the burr was rotating.Snares were used to remove the burr successfully after about 3 hours of extra work.After the detached burr was removed, the vessel was rewired and ballooned to finish the procedure.No patient complications were reported.

Manufacturer Narrative

Corrected d1 brand name from rotablator rotational atherectomy system to peripheral rotawire and wireclip torquer.Corrected d2a common device name from catheter, coronary, atherectomy to catheter, peripheral, atherectomy.Corrected d2b pro code (product code) from mcx to mcw.

Event Description

It was reported that the wire was fractured.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified anterior tibial vessel.A rotawire was selected to treat the entire length of the vessel.The 2.00mm peripheral rotalink plus made a stall sound when approximately 2-3 inches of the vessel was left to treat.Then, the rotapro catheter was removed but it was noted that the burr was sheared off and remained behind on the guidewire.It was also noted that the rotawire fractured when the burr was rotating.Snares were used to remove the device successfully after about 3 hours of extra work.After the detached burr was removed, the vessel was rewired and ballooned to finish the procedure.No patient complications were reported.

• Brand Name: PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: 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.; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18386855
• MDR Text Key: 331404875
• Report Number: 2124215-2023-73443
• Device Sequence Number: 1
• Product Code: MCW
• 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,Followup
• Report Date: 02/01/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• 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