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

Model Number H749236310030

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).The device was returned for analysis.Returned product consisted of the rotablator rotalink plus device.The advancer unit and burr unit were received together with the wireclip torquer in the wireclip torquer docking port.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically and visually examined.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The wireclip torquer was removed from the docking port and was clipped back in with no issues.Functional testing was performed by connecting the advancer to the rotablator control console system.The rotablator system was able to reach optimum speed with no issues and the burr catheter spun/moved with no issues and the brake worked properly.Product analysis confirmed that there was no issue with the device.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that the wireclip torquer loosened and became separated.The 90% stenosed target lesion was located in the moderately tortuous and severly calcified right coronary artery (rca).A 1.50mm rotalink plus was selected for use.During procedure the wireclip torquer became loose and separated.Upon removal of the burr with dynaglide; it was noted that the wireclip torquer separated immediately.The procedure was completed with this device and there were no patient complications reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the rotaburr and the rotawire were removed as a unit from the patient's body and the patient's condition was good.

• 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: 7627412
• MDR Text Key: 111986298
• Report Number: 2134265-2018-05604
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• Combination Product (y/n): N
• 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,Followup
• Report Date: 05/25/2018

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: 10/14/2019
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 21377415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• 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