MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS

Model Number	500-301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The component and heic code fields were intentionally left blank.A supplemental mdr to follow to enter the applicable component code upon availability (after device evaluation complete), and heic code (b)(4).The manufacturer is anticipating return of the device for evaluation, but has not received it at this time.
Event or Problem Description
During preparation for a lead extraction procedure, a spectranetics 12f glidelight laser sheath was calibrated for use.However, the physician then realized that a portion of the device's sheath near the tip was compromised, as it was reported that laser light was showing through.It was reported that the device was never used in the patient and was not kinked.The philips representative present in the procedure placed the glidelight device in a biohazard bag for return to the manufacturer for evaluation.Another 12f glidelight device was opened and the procedure was performed successfully with no reported 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 return of the device for evaluation, but has not received it at this time.
Additional Manufacturer Narrative
B5): this event is no longer reportable per the device analysis results.D9): the device was received by the manufacturer on 29 june 2021.H3): the device evaluation was completed on 01 july 2021.H6): in the initial mdr, hecc code 4565 was used, based on the information the manufacturer received in the initial complaint report.However, after the device evaluation and investigation were completed, this code has been corrected to 4582 (see device evaluation below).H6): added codes 772, 814, 4582, 2199, 10, 3211, and 67.Device evaluation: the device was returned and evaluated by a cross functional team on 01 july 2021.A kink was seen 11cm from distal tip, no breach or broken fibers were seen in this area.Just proximal to the device's distal marker band, one dead fiber was noted and red light was seen shining though the outer jacket.However, there was no breach to the outer jacket in this area.One dead fiber is within the specification for the device to be released for distribution.
Event or Problem Description
This event is no longer reportable for potential exposure to manufacturing materials and unintended radiation exposure.Per the returned device analysis, no breach in the device's outer jacket was detected.This event did not result in patient harm nor would it cause or contribute to patient harm with recurrence.

• Brand Name: SPECTRANETICS 12F GLIDELIGHT LASER SHEATH
• Common Device Name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11869216
• Report Number: 1721279-2021-00094
• Device Sequence Number: 19633706
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: (01)00813132020323(17)221215(10)FGA20M10A
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P960042
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2022
• Device Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: FGA20M10A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/15/2021
• 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: RA PACING LEAD MANUFACTURER UNKNOWN; RV PACING LEAD MANUFACTURER UNKNOWN; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; RA PACING LEAD MANUFACTURER UNKNOWN; RV PACING LEAD MANUFACTURER UNKNOWN; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR