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 Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010); Pulmonary Edema (2020); Cardiac Perforation (2513)

Event Date 08/05/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter address - (b)(6).

Event Description

It was reported that the patient experienced perforation resulting in additional intervention.A rotawire and rotapro were used for a high complexity case.The patient had severe disease to the native vessels.Treatment required atherectomy with different sized burrs.The lesion was crossed with a 0.014 guidewire then exchanged for a rotafloppy wire using a 2.0x8mm emerge balloon.Atherectomy was performed using a 1.5mm burr then the left anterior descending artery (lad) was wired.Atherectomy was performed with a 1.5mm burr but the lesion could not cross the lesion.The burr was exchanged for a 1.25mm.The 1.25mm burr and was able to pass the lesion.The left circumflex (lcx) was then wired.A perforation was observed.Patient became unstable and code blue was initiated and was emergently intubated.Bedside echo was performed which revealed a small effusion.A mamba micro catheter and a non-bsc wire crossed the lesion.Pre-dilation was performed with a 2.5x15mm emerge balloon.Ivus performed then stenting with a 2.5x22mm non-bsc drug eluting stent.Ivus was performed and the lad was pre-dilated with a 2.5x15mm emerge balloon.Ivus was performed with a non-bsc catheter that could not cross the lesion in the distal lad.Pre-dilation performed again with a 2.5x3mm emerge balloon and the lad was stented with a 2.5x38 non-bsc drug eluting stent.A 3.5x16mm megatron synergy was then attempted to be deployed but the stent balloon ruptured prior to full deployment.During removal attempts the shaft fractured.The right common femoral artery was identified via ultrasound.A micro puncture kit and modified seldinger technique with an 8f 45cm sheath was inserted along with a non-bsc wire.The patient became unstable.The 8f sheath was exchanged for a 14f impella sheath.Ct surgery consulted for emergent cabg.Cabg findings revealed that the left main large vessel had luminal irregularities.The lad was severely calcified and 99% stenosed.Pre-timi flow is 3 and post timi flow is 0.99% proximal stenosis was also observed in the left circumflex.The stent placed in the rca appeared patent.The patient experienced coronary perforation and acute vessel closure due to the stent entrapment.The following day, one-view chest radiograph revealed pleural effusion and worsening atelectasis of the left lung.Additional pulmonary opacities may be due to pulmonary edema.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15265391
• MDR Text Key: 298302815
• Report Number: 2134265-2022-08623
• 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: 08/22/2022

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: 08/08/2022
• Initial Date FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male