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

Model Number 3243

Device Problems Break (1069); Entrapment of Device (1212); Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

It was reported that the burr became stuck in the lesion and the shaft broke.The 80% stenosed target lesion was located in a moderately tortuous and severely calcified left main (lm) vessel.A 1.75mm rotapro was selected for use atherectomy procedure.During procedure, the rota pro stalled and the rota pro burr became stuck in the stenosis.The rotapro catheter continued to rotate distal to the rotpro burr.The drive shaft became loose and detached.A guide catheter was advanced for support.The guide catheter was pushed into the vessel to remove the detached portion of the drive shaft and rotapro burr.The fractured rotapro device was completely removed from the patient.The procedure was completed with non-complaint balloons and stents.No patient complications were reported.

Manufacturer Narrative

The event date was note reported.The first date of the month of the aware date was entered as an estimate.Initial reporter phone: (b)(6).

• 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 CORPORATION; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13675805
• MDR Text Key: 286642377
• Report Number: 2134265-2022-02162
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 03/04/2022

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: 12/14/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0028558747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1