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

Model Number	500-013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Iatrogenic Source (2498)
Date of Event	09/28/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device was discarded by the site.Therefore, evaluation is not possible.There is no allegation that a malfunction of the device caused or contributed to the reported event.
Event or Problem Description
A philips representative reported that a cardiac lead management procedure to remove a right ventricular (rv) lead commenced on (b)(6) 2018.The spectranetics sls ii laser sheath 500-013 was utilized to extract the lead without issue.The physician then put a guidewire in through the sls laser sheath for re-implant of an additional implantable cardioverter defibrillator (icd) lead.As the lead was placed, the patient's blood pressure began to slowly drop down into the 40s.Rescue efforts were implemented.After sternotomy was completed, the physician confirmed there was a tear in the innominate vein.They continued with the surgical rescue but the patient did not survive the procedure.

• Brand Name: SPECTRANETICS SLS II LASER SHEATH
• Common Device Name: SLS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7997540
• Report Number: 1721279-2018-00150
• Device Sequence Number: 1190713
• Product Code: MFA
• UDI-Device Identifier: 00813132020316
• UDI-Public: 00813132020316
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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
• Report Date (Section B): 09/28/2018
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2019
• Device Model Number: 500-013
• Device Catalogue Number: 500-013
• Device Lot Number: FKK17G07A
• Was Device Available for Evaluation?: No
• 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: 09/28/2018
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 57
• Date Report Sent to FDA: 01/01/2005