MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS SLS LASER SHEATH

Model Number	500-012
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction

• Brand Name: SPECTRANETICS SLS LASER SHEATH
• Common Device Name: SLS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7611011
• Report Number: 1721279-2018-00076
• Device Sequence Number: 16173480
• Product Code: MFA
• UDI-Device Identifier: 00813132020309
• UDI-Public: 00813132020309
• Initial Reporter Country: TW
• PMA/510(K) Number: P960042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2018
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/04/2018
• Device Model Number: 500-012
• Device Catalogue Number: 500-012
• Device Lot Number: FJJ16G29A012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Concomitant Medical Products and Therapy/Usage Dates: SPECTRANETICS CVX-300 EXCIMER LASER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Weight: 72
• Date Report Sent to FDA: 01/01/2005