MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Code Available (3191)

Event Date 08/11/2020

Event Type  Injury  

Event Description

It was reported that rotawire tip broke off and remained inside the patient's body.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 330cm rotawire and a rotaburr were selected for use.During the procedure, upon delivering the burr to the lesion, resistance was noted in the guide catheter.The physician then engaged dynaglide mode to advance the burr; however, it was noted that the radiopaque tip of the rotawire broke in the patient's vessel.The fractured wire body was removed, however the tip remained in the patient's body.Attempts was made to snare the tip of the wire but were unsuccessful.The procedure was completed with another of same device.No further patient complications were reported.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10442645
• MDR Text Key: 204024788
• Report Number: 2134265-2020-11540
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/24/2020
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR