MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK PERIPHERAL ROTALINK® PLUS; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number M0011402000

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: device was returned for analysis.Returned product consisted of a rotablator rotalink plus device.The advancer and burr units were received together.The advancer knob was received loosened in a mid-way position.The sheath, coil, and burr were microscopically and visually inspected.There was fibrous foreign matter on the coil and burr.Functional testing was performed by connecting the rotablator rotalink plus device to the rotablator control console system.The device was not able to get any speed and the console stall light came on.The advancer was dismantled and the turbine was found to be corroded and the ultem was found to be melted.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that the device was contaminated.The target lesion was located in the right superficial femoral artery.A 2.00mm peripheral rotalink® plus was selected to be used.During preparation, while platforming, the device hit the sterile towel and caused the burr to wrap some thread from the towel.The procedure was completed with another of the same device.No patient complications reported.

• Brand Name: PERIPHERAL ROTALINK® PLUS
• Type of Device: CATHETER, PERIPHERAL, 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5996024
• MDR Text Key: 56346950
• Report Number: 2134265-2016-08605
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: M0011402000
• Device Lot Number: 19524080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2016
• 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