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

Model Number H749236310020

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

Same case as: 2134265-2014-00642.It was reported that the burr overheated.The target lesion was located in the coronary artery.A 1.25mm rotablator rotalink plus was selected to treat the target lesion.During platform testing outside the patient, it was reported that the burr overheated which burned the "protective hub." the procedure was completed with a 1.5mm rotalink device.No patient complications were reported.

Manufacturer Narrative

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 manufacturer.The device was returned for analysis.Microscopic examination of the returned device revealed a burr was detached and not returned with the device.There was evidence of plastic melted to the coil of the catheter that was not covered by the introducer sheath.The coil of the distal shaft was also found to be stretched from the procedure.The melted plastic is likely to be that of the distal gripper that is applied to the burr to prevent damage to the burr before use.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.It was reported that ¿when the physician made a test outside the patient, before introducing the material into the patient, it was an overheat of the burr which has burned more or less the protective hub.¿ the testing of the device outside of the patient sees the burr rotating at high speeds which causes a friction and heat to build up.Considering the distal gripper is placed on the coil, there is potential for the gripper to melt onto the coil.It is likely the burr was detached as a result of this, as the coil was found to be stretched.The most probable root cause has been determined to be use/user error as the dfu gives detailed instructions on the proper set up of the rotablator system and states ¿gently remove the distal gripper from the burr.¿ (b)(4).

Event Description

Same case as: 2134265-2014-00642.It was reported that the burr overheated.The target lesion was located in the coronary artery.A 1.25mm rotablator rotalink plus was selected to treat the target lesion.During platform testing outside the patient, it was reported that the burr overheated which burned the "protective hub." the procedure was completed with a 1.5mm rotalink device.No patient complications were reported.

• 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: 3624515
• MDR Text Key: 4208844
• Report Number: 2134265-2014-00641
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/14/2014

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: 06/30/2015
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 0016270807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 02/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2013
• 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