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

Model Number	501-114
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hot Flashes/Flushes (2153); Iatrogenic Source (2498)
Date of Event	09/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead management case commenced to remove three leads: right atrial (ra), right ventricular (rv), and left ventricular (lv) leads due to infection.With use of a spectranetics visisheath, a lead locking device (lld) and a glidelight device model 500-302, the lv lead was successfully removed first, then removal of the ra lead was attempted next.However, significant lead on lead binding was encountered, so the physician then switched attempt to remove rv lead instead.Extensive manipulation of visisheath was performed in order to cross the binding.The rv lead was ultimately removed with success; however at this time patient''s blood pressure dropped.Rescue efforts commenced immediately including sternotomy.A tear in the patient''s innominate vein was discovered.The remaining ra lead was removed post sternotomy, repair of the injury was made and patient survived the procedure.

• 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: 7940952
• Report Number: 1721279-2018-00143
• Device Sequence Number: 857185
• Product Code: DRE
• UDI-Device Identifier: 00813132020392
• UDI-Public: 00813132020392
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 09/14/2018
• 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: 03/06/2020
• Device Model Number: 501-114
• Device Catalogue Number: 501-114
• Device Lot Number: FMM18C06A
• 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: 09/14/2018
• Initial Report FDA Received Date: 10/05/2018
• 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: Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 129
• Date Report Sent to FDA: 01/01/2005