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

Model Number 29710

Device Problem Entrapment of Device (1212)

Patient Problems Myocardial Infarction (1969); Vasoconstriction (2126)

Event Date 04/05/2021

Event Type  Death  

Event Description

It was reported that the rotaburr became stuck within the lesion, the rotaburr and rotawire were difficult to remove, the procedure was aborted, the patient went to surgery then later died during surgery. A 2. 00mm peripheral rotalink plus atherectomy catheter burr and a peripheral rotawire guidewire were selected for use in a tibial atherectomy procedure. The patient was being treated at an outpatient facility. The 100% stenosed target lesion was located in the mildly tortuous and severely calcified peroneal artery. The devices were advanced to the lesion and atherectomy was performed with a set rotational speed of 180,000rpm. The burr stalled and became lodged into the peroneal artery. The burr could not be removed from the peroneal artery. At the time the burr became stuck in the peroneal artery the patient experienced a vasospasm which may have played a role in the burr becoming stuck within the peroneal artery. The procedure was cancelled and the patient was transferred via an ambulance to the hospital to have the devices removed surgically. The peripheral rotawire guidewire was removed but the patient experienced a cardiac event including myocardial infarction. During the burr removal, the patient died. The burr was not recovered. There was no postmortem performed on the patient.

• Brand Name: PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11726882
• MDR Text Key: 247353240
• Report Number: 2134265-2021-05021
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 29710
• Device Catalogue Number: 29710
• Device Lot Number: 0026659023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/26/2021 Patient Sequence Number: 1