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

Model Number 3520

Device Problem Device Damaged by Another Device (2915)

Patient Problems Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Ischemia (1942); Myocardial Infarction (1969); Pain (1994); Stenosis (2263); Discomfort (2330); Cardiac Perforation (2513); Device Embedded In Tissue or Plaque (3165)

Event Date 01/29/2021

Event Type  Injury  

Event Description

It was reported that the rotaburr sheared the rotawire, perforation and patient complications occurred resulting in additional intervention.The target lesion was located in the left main to circumflex artery.A 1.25mm rotalink plus and a rotawire were selected for use.During procedure, after the third pass, it was noted that the rotawire was sheared and the distal part of wire was left in the circumflex.Consequently, the rest of rotablator system was removed.The physician was unable to re-cross vessel and the patient coded.Then, an emergent balloon pump was inserted to stabilize patient.After iliac intervention, balloon pump was swapped for impella and continued to work on coronaries.The physician stented circumflex with a non boston scientific covered stent to seal perforation.Then, echmo replaced impella.The next day impella cp replaced echmo.Physician thought the rotawire prolapsed and the burr severed it while trying to advance.Patient complications noted were arrhythmia, discomfort/pain, myocardial infarction/ischemia, st segment elevation and vessel occlusion.The patient was stable the next day but still critical.

• 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: 11323026
• MDR Text Key: 231650508
• Report Number: 2134265-2021-01622
• 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: 02/12/2021

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: 3520
• Device Catalogue Number: 3520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2021
• Initial Date FDA Received: 02/12/2021
• 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: ATHERECTOMY SYSTEMS AND DEVICES: ROTALINK PLUS
• Patient Outcome(s): Other; Required Intervention