MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK¿ PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number H749236310020

Device Problem Physical Resistance (2578)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a rotablator rotalink plus device with the rotawire for the related complaint.Microscopic examination of the device revealed that the annulus was damaged, not rounded and flared.The annulus was blocked due to the damage.The damage to the annulus is consistent with damage caused by the rotating burr coming into contact with the guidewire during use.The rotawire used in the procedure was returned for product analysis, so functional testing was completed with this rotawire.Even though the rotawire was received fractured, it could still be used for functional testing by attempting to insert the proximal end of the wire into the annulus.The wire was not able to be inserted into the annulus due to the damage and it being blocked.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-02465.Reportable based on device analysis completed on 17-feb-2018.It was reported that the burr would not load onto the rotawire.A 1.25mm rotalink¿ plus and a rotawire¿ were selected for use in a coronarography room.During the procedure, it was noted that the rotaburr would not load onto the rotawire.No patient complications were reported.However, device analysis revealed that the rotawire was fractured.

• Brand Name: ROTALINK¿ PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7338330
• MDR Text Key: 102448580
• Report Number: 2134265-2018-01690
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2018

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 Expiration Date: 05/31/2017
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 18149192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2018
• Initial Date FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2015
• 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