MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 12F GLIDELIGHT LASER SHEATH

Model Number	500-301
Medical Device Problem Codes	Break (1069); Temperature Problem (3022)
Health Effect - Clinical Codes	Burn(s) (1757); Burning Sensation (2146); Superficial (First Degree) Burn (2685); Radiation Exposure, Unintended (3164)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is awaiting return of the device for evaluation but it has not been returned at this time.
Event or Problem Description
A lead extraction procedure commenced.While the physician was using a spectranetics glidelight laser sheath, he was holding the laser sheath by the handle and his right little finger was against the joint (junction) between the device bifurcate handle and the working length of the laser sheath.It was reported that the physician felt a popping sensation against his hand, and he stopped lasing at that time.It was reported that a small hole had been created through both layers of the physician's gloves, as the handle heated up and the physician realized the device had started to break at the junction between the bifurcate handle and the device.A 1mm area of skin was affected on the physician's finger; this area required no treatment.The procedure was completed without patient harm.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.The manufacturer is anticipating the return of the device for evaluation but it has not been returned at this time.
Additional Manufacturer Narrative
D10): device was returned to manufacturer on (b)(6) 2019.H6): method, results and conclusions codes populated after device evaluation was completed.Device evaluation: the device was evaluated on (b)(6) 2020 by a cross functional engineering team.Upon initial observation, the device's outer sheath remained on the glidelight laser sheath, and it appeared the outer sheath had been cut at the proximal end.The team observed heavy dilation damage at the distal tip of the outer sheath.A kink was present on the device's working length, occurring at the bifurcate handle of the device.There was a confirmed breach in the device's outer jacket with confirmed broken fibers in this area.It was determined the device became kinked and then broken fibers at the area of the kink produced heat, which created a breach in the device's outer jacket.Historically, the manufacturer has observed this failure at the device's bifurcate handle when excessive forces are applied to the side of the device's outer jacket, at or near the bifurcate handle.This failure has been determined to be use related.H3 other text : placeholder.

• Brand Name: SPECTRANETICS 12F GLIDELIGHT LASER SHEATH
• Common Device Name: GLIDELIGHT
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9492531
• Report Number: 1721279-2019-00222
• Device Sequence Number: 1189751
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: (01)00813132020323(17)210917(10)FGA19J11A
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P960042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2021
• Device Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: FGA19J11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPECTRANETICS CVX-300 EXCIMER LASER.
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005