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

Model Number H749 23631-004 0

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2016

Event Type  malfunction  

Event Description

Device failure included rotoblator leaking rotoglide lubricant.Physician requested vendor be notified.Vendor removed device and reported complaint through their company (boston scientific).Per md: "rotoblator stall in a patient.I pulled the device out and i saw a pinpoint hole in the shaft of the device.".

• Brand Name: ROTALINK
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 6221587
• MDR Text Key: 63846905
• Report Number: 6221587
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: H749 23631-004 0
• Device Catalogue Number: H749 23631-004 0
• Device Lot Number: 19726813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1