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

Model Number 3320

Device Problem Entrapment of Device (1212)

Patient Problems Chest Pain (1776); ST Segment Elevation (2059)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated off of case study publication date.Case study source: abdellaoui, m., & faurie, b.(2019, april 04).Case study: my most memorable radial case - a stuck rota burr.Retrieved from pcr online: https://www.Pcronline.Com/cases-resources-images/complications/implant-loss/coronary-embolised-devices/rotablator/case-library/case-study-my-most-memorable-radial-case-a-stuck-rota-burr.

Event Description

It was reported that the burr became stuck in the lesion.A 1.5mm rotablator burr and rotawire was selected for an atherectomy procedure in the calcified right coronary artery.A radial approach was used to access the lesion and tortuosity was observed in the radial and brachial arteries.Initially the rotawire failed to cross so another non-bsc wire was used to cross the lesion successfully, followed by use of another rotawire.During the procedure, the burr became stalled and stuck in the lesion.The patient experienced chest pain and inferior st-elevation.A second radial access was done to cannulate the right coronary artery (rca) with another guide catheter after decannulation of the first guidewire.After a failed attempt to cross a balloon along the burr, the knuckle wire technique was used with a non-bsc wire in an attempt to remove the burr.Balloon inflation attempts were made to dislodge the burr and the burr was ultimately removed with deep intubation.A 1.25mm rotablator burr was used successfully and two stents were implanted.No additional patient complications were reported.

• Brand Name: ROTALINK BURR
• 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: 10421097
• MDR Text Key: 203352329
• Report Number: 2134265-2020-11225
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2020

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: 3320
• Device Catalogue Number: 3320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/18/2020
• 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
• Treatment: ROTAWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR