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

Model Number 3243

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2020

Event Type  Injury  

Event Description

It was reported surgical intervention was required to remove an entrapped burr.The target lesion was located in the distal right coronary artery (rca) in which a stent had been previously implanted.A 1.50mm rotapro was selected for use in an atherectomy procedure.During the procedure, the burr became entrapped in the lesion in the stented area of the rca.A 7fr guide catheter and 7fr guidezilla guide extension catheter were used to remove the burr.However, the guidezilla could not be advanced to the burr.A second guide catheter was inserted through the opposite (left) groin and attempted to wire along the entrapped burr without success.The rotapro burr hub was then cut off, and the burr fluid sheath and guidezilla were removed.A 2mm non-bsc snare catheter was placed but the snare shaft snapped when pulling on the burr.A second snare was used but could not remove the burr.The patient remained stable during all intervention attempts, and then the patient was sent to the operating room for successful coronary bypass grafting.The patient is currently stable.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10737660
• MDR Text Key: 213177133
• Report Number: 2134265-2020-14033
• 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: 10/26/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/26/2020
• 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): Required Intervention