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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Low Blood Pressure/ Hypotension (1914); Pain (1994); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 06/24/2020

Event Type  Death  

Event Description

It was reported that a patient death occurred.A 1.5mm rotapro and rotawire were selected for use in a complex percutaneous coronary intervention (pci) procedure.The target lesion was located from the left main coronary artery to the proximal mid circumflex artery.A choice pt guidewire was initially attempted to wire the lesion followed by a non-bsc wire and fighter wire.A non-bsc device was used to exchange the guidewire to a rotawire once access was obtained four passes with the 1.50mm rotapro burr were made from the left main coronary artery to the mid circumflex without complication.After angiographic review, the vessel appeared open with mild slow flow but no obvious dissection.The patient then experienced pain, and hemodynamic changes occurred.Blood pressure dropped and medication was given.A trapper device was used to assist in removal of a non-bsc catheter.Access to the vessel was lost and blood was noted within the trapper balloon at the end of the case and the balloon would not hold pressure.The vessel was re-wired without difficulty.Cpr was in progress by this time.A 2.5x20 emerge was inserted and inflated.Cpr continued and at the time the patient was intubated.The circumflex was ballooned in mid and proximal, but the balloon ruptured.A 2.75x20 balloon was inserted and inflated in the proximal circumflex.Angiography was performed.A 2.75x38mm synergy stent was inserted in the mid circumflex.Patient cpr and code continued.The patient cardioverted from ventricle tachycardia (vt) and ventricle fibrillation (vf) throughout this time.A temporary pacemaker was inserted to attempt to gain a conducting rhythm.A second synergy stent was placed in proximal circumflex and left main artery.The patient continued to be unresponsive to cpr, the pacemaker, or medications and continued to have no pulse.All resuscitation efforts were stopped at this point.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10268025
• MDR Text Key: 198629399
• Report Number: 2134265-2020-09162
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/13/2020
• 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
• Treatment: 1.50MM ROTAPRO; 2.5X20 EMERGE BALLOON; 75X38MM SYNERGY STENT; CHOICE PT WIRE; FIGHTER WIRE; TRAPPER BALLOON; TURNPIKE 135CM; WHISPER WIRE
• Patient Outcome(s): Death
• Patient Age: 79 YR