MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number H802220200381

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the pressure became unstable.A rotablator console was selected for use.During preparation, it was noted that the speed was unstable.The procedure was completed with this device.No patient complications were reported and the patient's status was stable.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7620798
• MDR Text Key: 111905562
• Report Number: 2134265-2018-05490
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/29/2018

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: H802220200381
• Device Lot Number: RC400779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1