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

Model Number H749236310030

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

It was reported that an unstable speed occurred.A 1.50mm rotalink plus was selected to treat the target lesion.During preparation for an atherectomy procedure, it was observed that there was air leakage near the air hose where the advancer is connected.The device was then tested with the intended speed of 170,000 rpm.The operator noticed on the display that the rotation speed was not stable.The procedure was completed with another of the same device.There were no patient complications reported and the patient's condition was stable.

Manufacturer Narrative

Age at time of event: under 18 years.Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for investigation.The catheter and the advancer were connected upon return.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 no damage was noted.A tug test was attempted to examine the integrity of the connection and no issues were noted.The drive shaft was also inspected and there was no damage noted.The device was wet tested and the rotablator system was unable to reach optimum speed as the device stalled.The advancer was dismantled and the ultem was found to be melted.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).

Event Description

It was reported that an unstable speed occurred.A 1.50mm rotalink¿ plus was selected to treat the target lesion.During preparation for an atherectomy procedure, it was observed that there was air leakage near the air hose where the advancer is connected.The device was then tested with the intended speed of 170,000 rpm.The operator noticed on the display that the rotation speed was not stable.The procedure was completed with another of the same device.There were no patient complications reported and the patient's condition was stable.

• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3793718
• MDR Text Key: 4365283
• Report Number: 2134265-2014-02494
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0016301167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2013
• 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