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 Patient Involvement (2645)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

Same case as: 2134265-2014-00641.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

(b)(4).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 that the burr was detached and not returned with the device.The testing of the device outside of the patient sees the burr rotating at high speeds.It is likely the burr was detached as a result of this, as the coil was found to be stretched.It is probable that during the testing of the rotablator plus unit, the rotating burr came in contact with the guidewire causing the burr to become stuck on the guidewire and detach.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

Same case as: 2134265-2014-00641.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: 3624564
• MDR Text Key: 4209355
• Report Number: 2134265-2014-00642
• 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: 08/31/2015
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 0016401601
• 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: 09/30/2013
• 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