MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE DRIVE; CATHETER, CORONARY, ATHERECTOMY

Model Number 2077-01

Device Problems Fracture (1260); Difficult to Advance (2920)

Patient Problems Chest Pain (1776); Perforation of Vessels (2135); Foreign Body In Patient (2687)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported that the rotawire broke and perforation occured.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified circumflex artery.An ng rotawire floppy single was selected for use during a heart catheterization (coronary angiogram) and percutaneous coronary intervention (pci).During the procedure, the wire was placed into a coronary artery and was lodged into calcium and the distal part with the radiopaque marker broke off.A 6 french guiding catheter was used.Intravenous heparin was administered, and a 0.014 whisper wire was then advanced into the left main.It was rather difficult to advance a wire into the circumflex artery.Subsequently a whisper wire was advanced into the circumflex artery to cross the left main and om lesions.Then, a 1.5 mm balloon was attempted to advance into the lesion but was unsuccessful despite a telescope catheter for support.Rotablator was then used with a corsair catheter and exchanged the wire for a roto floppy wire.Once the equipment is set up, 1.25 mm per was platformed outside the body.At the same time, the patient complained of chest pain with evidence of st depression on ekg.Fluoroscopy was also done and noted vessel perforation and rotablator wire was noted to be broken off.Anticoagulation was then reversed, and the doctor from ct surgery was notified.Given the fact the patient was post prior coronary artery bypass, it was unlikely the patient would accumulate any significant pericardial effusion.A bedside echocardiogram was performed, that demonstrated no pericardial effusion.No further complications were reported.

• Brand Name: ROTAWIRE DRIVE
• 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; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18385908
• MDR Text Key: 331286037
• Report Number: 2124215-2023-72712
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056/S166
• 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: 12/22/2023

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
• Device Model Number: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0029588401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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): Other
• Patient Age: 75 YR