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

Model Number 3240

Device Problem Output Problem (3005)

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); ST Segment Elevation (2059)

Event Date 10/15/2020

Event Type  Injury  

Event Description

It was reported that the burr was difficult to remove.A rotalink plus rotablator rotational atherectomy system were selected for use.After the third passage, the burr unexpectedly stopped downstream from the lesion.Several attempts were made to start rotation, however, rotation stopped within 5 seconds.Dynaglide function was not working.It was not possible to remove the burr and the patient experienced st segment elevation coronary syndrome and chest pain.The patient required deep intubation, sedation, injection of arterial vasodilators, and parallel placement of a guide in order to remove the burr from the circumflex artery.No further patient complications were reported.

Event Description

It was reported that the burr was difficult to remove.A rotalink plus rotablator rotational atherectomy system were selected for use.After the third passage, the burr unexpectedly stopped downstream from the lesion.Several attempts were made to start rotation, however, rotation stopped within 5 seconds.Dynaglide function was not working.It was not possible to remove the burr and the patient experienced st segment elevation coronary syndrome and chest pain.The patient required deep intubation, sedation, injection of arterial vasodilators, and parallel placement of a guide in order to remove the burr from the circumflex artery.No further patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the rotablator console rc401724 was received in good condition, but the warranty label was broken.The footpedal and airhose were received in good condition.A functional test showed the footpedal passed the specifications for cis rotablator functional test.A functional test showed the airhose passed the specifications for cis rotablator functional test.Functional testing of the console showed the console failed the specifications for cis rotablator functional test.The rotablator console failed functional testing on the pneumatic test fixture.It also failed functional testing on the pressure gauge on the device.These failures of low pressure can cause intermittent failure to reach optimum speeds during a procedure.The dynaglide mode functioned as it should throughout the functional test.

• 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
• MDR Report Key: 11211076
• MDR Text Key: 228166631
• Report Number: 2134265-2021-00615
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

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: 3240
• Device Catalogue Number: 3240
• Device Lot Number: RC401724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention