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

Model Number 3520

Device Problems Entrapment of Device (1212); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2018

Event Type  malfunction  

Event Description

It was reported that the burr entrapment on guidewire occurred.Two 1.50mm rotapro catheters and two 330cm rotawires were selected for an atherectomy procedure in an unspecified lesion.The first guidewire was inserted into the patient and the first burr was loaded onto the guidewire until the hemostatic valve in order to proceed to the draw test.The speed was increased from 160000 to 180000 rpm and at that time, the guidewire broke outside the patient, between the distal part of the burr and the hemostatic valve.The part of the guidewire remaining in the patient has been successfully removed from the patient since a part were reachable in front of the hemostatic valve.The second rotawire was inserted into the patient and an attempt to load the same burr was performed; however this attempt failed.The second rota burr was then selected.The draw test was successful and rotablator procedure was successfully achieved.During the dynaglide process, both the guidewire and the burr were withdrawn from the patient stuck together.There were no patient complications and the patient's status is okay.

• 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: 8285673
• MDR Text Key: 134362379
• Report Number: 2134265-2019-00474
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185871
• UDI-Public: 08714729185871
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2020
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0022709974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/29/2019
• 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
• Patient Age: 68 YR