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

Model Number H749236310030

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil and burr were microscopically and visually examined.The advancer unit and the burr units were received attached together as a single unit.The advancer knob was received tightened in a backward position.There was 1cm of fibrous foreign material (fm) on the coil at the end of the coil where the burr is attached.Inspection of the device presented no kinks or other irregularities to the device.The guidewire used in the procedure was not returned for product analysis, so functional testing was completed with a test rotawire.The rotawire was able to be inserted into the burr and advanced through the device with no issues.Inspection of the remainder of the device presented no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2017.It was reported that the burr would not load onto the wire and the shaft became kinked.A 1.50mm rotalink¿ plus was selected for use in a rotational atherectomy treatment procedure along with a floppy rotawire.The floppy rotawire was replaced with an extra support rotawire and the burr was attempted to be loaded on to the wire but was unsuccessful.The burr was replaced with a different device and the procedure was completed.No patient complications were reported.However, device analysis revealed fibrous foreign material on the shaft.

• 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: 6734206
• MDR Text Key: 80789295
• Report Number: 2134265-2017-06961
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: (01)08714729228363(17)20190228(10)20394720
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2017

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: 02/28/2019
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 20394720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• 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