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

Model Number H749236310020

Device Problems Thermal Decomposition of Device (1071); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2013

Event Type  malfunction  

Event Description

It was reported that a burning smell was observed and the burr became sticky.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 1.25mm rotalink plus burr was selected for rotational atherectomy.Pre-dilation was not performed.Platform testing was completed outside of the patient with no issues noted.While attempting to ablate the target lesion, a burning smell was observed and they were unable to increase the rotational speed of the burr above 7000rpm.The device was removed and it was further noted that the burr felt sticky and the physician thought it might be slightly melted.There were no patient complications reported and the patient¿s condition was stable.This procedure was not completed.Due to the severity of his lesion, the patient underwent surgery which was reported to be successful.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: the device was received for analysis.A visual examination of the returned device noted that the burr had been pulled back into the protective sheath.There was evidence of burning/overheating on the distal part of the sheath around the burr.When the handshake connection of the rotablator plus unit was inspected, it was noted that there was no connection made, i.E.The catheter unit separated from the advancer.The catheter body was taken apart; it was noted that the trifilar coil had doubled over itself and was jammed in the catheter sheath with the catheter handshake connector.The event description was confirmed as there was evidence of burning/overheating of the catheter sheath as a result of the interaction between the spinning burr and catheter sheath.This more than likely caused the reported speed issues also.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

It was reported that a burning smell was observed and the burr became sticky.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 1.25mm rotalink¿ plus burr was selected for rotational atherectomy.Pre-dilation was not performed.Platform testing was completed outside of the patient with no issues noted.While attempting to ablate the target lesion, a burning smell was observed and they were unable to increase the rotational speed of the burr above 7000rpm.The device was removed and it was further noted that the burr felt sticky and the physician thought it might be slightly melted.There were no patient complications reported and the patient¿s condition was stable.This procedure was not completed.Due to the severity of his lesion, the patient underwent surgery which was reported to be successful.

• 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: 3590942
• MDR Text Key: 4161810
• Report Number: 2134265-2014-00324
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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: 12/31/2013

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: 07/31/2015
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 0016317038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2014
• Initial Date FDA Received: 01/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2013
• 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
• Patient Age: 68 YR