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

Model Number 3243

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Output Problem (3005)

Patient Problem No Code Available (3191)

Event Date 07/27/2020

Event Type  Injury  

Event Description

It was reported that the burr became stuck in the lesion and detached.The 99% stenosed target lesion was located in the tortuous and severely calcified coronary vessel.A 1.5mm rotapro and a rotawire were selected for use in the percutaneous coronary intervention (pci) procedure of the circumflex (cx) artery.The device was prepared outside the body and platformed at 160,000rpm.During the procedure, the burr was advanced through the mamba guide catheter and a pecking motion was used during advancement.After multiple runs were performed, some degree of deceleration was noted in the rpms when the burr was engaged with heavily calcified lesion.During the fifth run, the proximal section of the burr had sheared off and the burr became stuck in the lesion.Another wire was passed and a 2.5mm apex balloon catheter was used to dislodge the burr.The physician then removed the devices successfully by pulling out the sheared burr and rotawire together.The procedure was completed successfully with balloons and stents.There were no patient complications reported and the patient's status was good post procedure.

• 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 SCIMED, INC; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10397849
• MDR Text Key: 202597959
• Report Number: 2134265-2020-10960
• 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: 08/12/2020

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: 07/27/2020
• Initial Date FDA Received: 08/12/2020
• 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: BOSTON SCIENTIFIC - 2.5MM APEX BALLOON CATHETER
• Patient Outcome(s): Required Intervention