MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS VISISHEATH DILATOR SHEATH

Model Number	501-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation of Vessels (2135)
Date of Event	08/08/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient weight unavailable.
Event or Problem Description
A procedure commenced to extract two leads: a right atrial (ra) lead and a right ventricular (rv) lead due to non function and occlusion.Both leads were successfully extracted with use of a spectranetics visi sheath model 501-016, a glidelight device model 500-303, tightrail devices and a lead locking device (lld).However, while placing wires for a re-implantation through the laser and visi sheath, the patient's blood pressure dropped.Rescue efforts commenced immediately, including sternotomy.A superior vena cava (svc) tear was discovered.Despite rescue efforts and attempted repair of injury, the patient did not survive.

• Brand Name: SPECTRANETICS VISISHEATH DILATOR SHEATH
• Common Device Name: VISISHEATH
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7825202
• Report Number: 1721279-2018-00116
• Device Sequence Number: 1249179
• Product Code: DRE
• UDI-Device Identifier: 00813132020378
• UDI-Public: 00813132020378
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K092378
• 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): 08/08/2018
• 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: 01/25/2019
• Device Model Number: 501-016
• Device Catalogue Number: 501-016
• Device Lot Number: FVL17A25A
• 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: 08/08/2018
• Initial Report FDA Received Date: 08/28/2018
• 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
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005