MAUDE Adverse Event Report: BOSTON SCIENTIFIC ROFALINK; ROTOLINK PLUS 1.5M

Catalog Number 23631-003

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Fracture (1260)

Patient Problems Extravasation (1842); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)

Event Date 06/06/2014

Event Type  Death  

Event Description

Coronary rotational atherectomy burr detached from its drive shaft.The atherectomy burr stalled or was impinged in the heavily diseased and calcified coronary artery.The shaft that drives the burr fractured at its attachment to the burr.In the process of retrieving the burr from the coronary artery a dissection occurred causing extravasation and cardiac tamponade.

• Brand Name: ROFALINK
• Type of Device: ROTOLINK PLUS 1.5M
• Manufacturer (Section D): BOSTON SCIENTIFIC; maple grove
• MDR Report Key: 3949439
• MDR Text Key: 18866934
• Report Number: MW5037302
• Device Sequence Number: 1
• Product Code: MCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 23631-003
• Device Lot Number: 1683900
• Other Device ID Number: (01)08714729228363
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Weight: 70