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

Model Number 3243

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Perforation of Vessels (2135)

Event Date 04/12/2019

Event Type  Injury  

Event Description

It was reported that a vessel perforation occurred.The target lesion was located at the bifurcation of the ramus artery.The ramus was at a 90 degree angle and had multiple previously implanted stents.The bifurcation was double wired and a 2.0 x 6 wolverine was used to pre-dilate a side branch.One of the guidewires was exchanged for a rotawire floppy and then a 1.25 rotapro was used for atherectomy.On the second run the burr perforated the artery wall.The perforation in the ramus was treated with prolonged balloon inflation.The ramus then shut down causing thrombosis in the left anterior descending (lad) artery.The lad was subsequently opened with a balloon.The ramus remained closed.The patient remained okay throughout and has since been discharged.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8586580
• MDR Text Key: 144276841
• Report Number: 2134265-2019-04868
• 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: 05/07/2019

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?: No
• 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: 04/15/2019
• Initial Date FDA Received: 05/07/2019
• 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: FIELDER GUIDEWIRE; MACH1 VL3.5 GUIDE CATHETER; RUNTHROUGH GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR