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

Device Problem Fracture (1260)

Patient Problem Perforation (2001)

Event Date 09/15/2023

Event Type  Injury  

Event Description

It was reported that perforation has occurred.The target lesion was located in the severely tortuous and severely calcified right coronary artery (rca).Two 1.50mm rotapro and a rotawire were selected for percutaneous coronary intervention (pci) procedure.During the procedure, the physician used the first 1.5 rotapro burr at the proximal portion of the vessel.After the burr was worn down, a second 1.5 rotapro burr was opened and advanced to treat the distal rca.However, the wire fractured while drilling around a u curve bend lesion.The physician moved or adjusted the wire once, but the wire fractured which resulted in vessel perforation.The proximal part of the wire and the burr was simply removed altogether, and the fractured portion was left in the vessel trapped by coils.The patient went extracorporeal membrane oxygenation (ecmo) post procedure and is doing better now after ecmo was removed.No further complications were reported.

• 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.
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17864793
• MDR Text Key: 324848221
• Report Number: 2124215-2023-54287
• 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: 10/03/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/03/2023
• 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