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

Model Number M0011401500

Device Problems Entrapment of Device (1212); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2015

Event Type  malfunction  

Event Description

Same case as mdr id:2134265-2015-01023.It was reported that the burr was stuck on the rotawire.The chronic totally obstructed target lesion was located in a tortuous and severely calcified right anterior tibial artery.A 1.50mm peripheral rotalink® plus and an unspecified size peripheral rotawire¿ were used for treatment.During procedure, it was observed that the rotation speed of the device significantly dropped from 220,000rpm to 160,000rpm.It was then observed that the burr was locked onto the guidewire and was stuck.Both devices were removed from the patient's body.The procedure was not completed since the access across the target lesion was lost.There were no patient complications reported and the patient's condition was good.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The complaint unit was returned connected to the catheter.A guidewire was returned inserted in the rotablator plus unit and was removed from the device without any issue.A visual examination of the complaint unit was carried out and no issues were noted.The advancer knob was locked upon return in a backward position; it was loosened and advanced in order to inspect the handshake connection and no damage was noted.A handshake connection test and a tug test was attempted to examine the integrity of the connection and no issues were noted.The drive shaft, coil and sheath were inspected and there was no damage noted.The complaint unit was wet tested.The complaint rotablator system did not reach any speed as the device stalled.The device was dismantled and was found out that a melted ultem and a corroded turbine was evident.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 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).

• 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: 4570241
• MDR Text Key: 19600440
• Report Number: 2134265-2015-01024
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2015

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: 08/31/2016
• Device Model Number: M0011401500
• Device Lot Number: 17182126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2014
• 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
• Patient Age: 82 YR