MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER; TURBO ELITE

Model Number 420-006

Device Problems Radiation Leak (1357); Material Perforation (2205)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685); Radiation Exposure, Unintended (3164)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is physician's information as it was the physician that was burned, not the patient.Physician's age and weight were not provided.Although return has been requested, the suspect device has not been received by the manufacturer for evaluation.

Event Description

A philips vascular intervention representative reported that during a peripheral atherectomy procedure, the spectranetics turbo-elite atherectomy laser catheter 420-006 got hot and burned through the physician's gloves, burning his right hand.He felt this occur as he advanced the catheter after the last pass (2nd pass).The only intervention needed was changing his gloves (as the catheter had burned through them) and running his hand under cold water.This issue did not affect his ability to finish the procedure or perform any others.It was reported that a breach was seen in the catheter jacket.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.

Manufacturer Narrative

Additional information received on 6 march 2019 regarding this event and has been populated in this section.Serial number now provided.Device received at manufacturer facility on 12/07/2018.The turbo-elite device was initially evaluated on 07 feb 2019.A visual inspection identified no kinks, holes, or thermal breaches in the jacket.When the catheter was plugged into simulated laser light, a broken fiber was found about 53cm from the tip but did not breach the outer jacket.The evaluation determined no malfunction or other deficiency with the turbo elite catheter.The reported event was unrelated to the appropriate operation of the device.Reevaluation took place on 28th february 2019.Confirmed no breach in the jacket.Unintended radiation exposure patient code 3164 used due to the report that the laser system''s pedal may have been depressed at the time the physician reportedly burned his hand while touching the distal tip of the turbo elite catheter after it was removed from the patient''s body.

Event Description

Additional information obtained via a phone call on 6 march 2019 from the rep who was present at the procedure, since the device evaluation showed no evidence of a malfunction of the device, nor was there a breach in the device''s outer jacket, not able to explain the report of the physician''s glove and hand being burned.Rep stated that after the physician had made two passes with the laser catheter through a very long lesion and the laser catheter was out of the patient''s body, she witnessed the physician touching the distal tip of the laser, and that is the time that the reported event occurred.Rep stated she didn''t know if the laser''s footpedal was depressed at the time.Rep stated that this physician was a newer user of the laser system at the time of the event.After the event, retraining/education was completed to the physician by rep and strategic account manager.The initial device evaluation and subsequent re-evaluation determined no malfunction or other deficiency with the turbo elite catheter.The reported event was unrelated to the appropriate operation of the device.This follow up mdr is being filed to report the results of the device evaluations and additional follow up, along with the potential of accidental radiation exposure if the foot pedal was depressed after the device was removed from the patient''s body.

• Brand Name: SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8043943
• MDR Text Key: 126354735
• Report Number: 1721279-2018-00156
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: 00813132024758
• Combination Product (y/n): Y
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2020
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA18G23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Patient Outcome(s): Required Intervention