MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number 3520

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/25/2018

Event Type  Injury  

Event Description

It was reported that patient condition was not good the 90% stenosed target lesion was located in severely calcified mid to distal left circumflex artery.A 1.25mm rotalink plus and a rotawire were selected for use.During the procedure, 1.5/15 non-bsc balloon was entered through a non-bsc wire but failed due to calcification severity and tortuosity.A rotawire was placed and the rotalink was advanced over the rotawire, however, it was noted that the patient was not good before the start of the ablation procedure.The procedure was completed a different device.No further patient complications were reported.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8025567
• MDR Text Key: 125701619
• Report Number: 2134265-2018-62489
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2018

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: 3520
• Device Catalogue Number: 3520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 10/31/2018
• 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
• Patient Age: 75 YR