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

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/20/2018

Event Type  Injury  

Event Description

It was reported that the burr became stuck in the lesion and detached requiring surgery.The target lesion was located in coronary artery.A rotablator burr and a rotawire were selected for use.During the procedure, the burr became stalled in the coronary artery.Consequently, the burr detached from the drive shaft when it was pulled in attempt for removal.The patient was then sent to surgery and the burr was successfully removed.No further complications were reported and patient is fine.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8164887
• MDR Text Key: 130355717
• Report Number: 2134265-2018-64059
• Device Sequence Number: 1
• Product Code: MCX
• 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: Physician
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention