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

Model Number H749236310050

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older (b)(4).Device evaluated by mfr: the advancer unit was returned connected to the catheter unit.A guidewire was returned running through the device.A visual examination of the complaint unit revealed no visual issue was noted with the advancer unit or catheter.The advancer knob was locked upon return in a backward position, it was loosened and advanced in order to inspect the handshake connection.The handshake connection was inspected and a tug test was performed and no damage was noted.The rotawire was removed.The burr was microscopically examined and no issues were noted with the annulus of the burr.A scratch test was performed to confirm if the returned burrs cutting action was acceptable.The diamond plated area of the burr was scratched along the side of a single edge blade.When the side of the blade was visually examined, a scratch mark from where the burr came into contact with the side of the blade was noted and that the burrs cutting action was acceptable.When the advancer was hooked up to the saline infusion, saline was found to be leaking from the catheter sheath under the strain relief.The strain relied was removed and saline was expelled from the catheter shaft.The catheter shaft was inspected and a tear was noted on the catheter sheath.The catheter was disconnected from the advancer and a test catheter was attached.A further attempt was made to wet test the unit.No speed was met.The advancer unit was dismantled and it was noted that the turbine was seized and a melted ultem was evident.Product analysis showed a corroded turbine.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the dfu 90979303-01 states: ¿never operate the rotablator advancer without saline infusion.Flowing saline is essential for cooling and lubricating the working parts of the advancer.Operation of the advancer without proper saline infusion may result in permanent damage to the advancer¿.(b)(4).

Event Description

Reportable based on device analysis completed on 12may2016.It was reported that a device stall occurred.The target lesion was located in the severely calcified coronary artery.A 2.00mm rotalink¿ plus was selected for use; however, the device stalled its rotation speed in the platform during the insertion.The procedure was completed with another of the same rotalink¿ plus.No patient complications were reported and the patient's status is good.However, device analysis revealed that the catheter sheath was torn under the strain relief.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5717562
• MDR Text Key: 47207564
• Report Number: 2134265-2016-04773
• Device Sequence Number: 1
• Product Code: MCX
• 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: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: H749236310050
• Device Catalogue Number: 23631-005
• Device Lot Number: 18558233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2015
• 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