MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT; CATHETER, CORONARY, ATHERECTOMY

Model Number 3240

Device Problems No Display/Image (1183); Activation Problem (4042)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2018

Event Type  malfunction  

Event Description

It was reported that the console rpm displayed intermittently.A rotablator rotational atherectomy system console kit was selected for use.It was noted that the rotablator console failed to go into dynaglide mode and the rpm display worked intermittently.No patient involvement reported.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8038095
• MDR Text Key: 126170728
• Report Number: 2134265-2018-62566
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729353300
• UDI-Public: 08714729353300
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2018

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 Model Number: 3240
• Device Catalogue Number: 3240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1