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

Model Number 3320

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2019

Event Type  malfunction  

Event Description

It was reported that the catheter leaked saline.A 1.50mm rotablator rotalink burr was selected for an atherectomy procedure.During preparation of the device, the device would not drip correctly.A hole was noted in the catheter fluid line which caused a leak.The device was not advanced into the patient.Another of the same device was used to complete the procedure.There were no patient complications reported.

• Brand Name: ROTALINK BURR
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9440009
• MDR Text Key: 175877914
• Report Number: 2134265-2019-15301
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2019

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 Expiration Date: 01/08/2021
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0023316806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2019
• 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