MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH

Model Number	545-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiomyopathy (1764); Death (1802); Endocarditis (1834); Sepsis (2067); Perforation of Vessels (2135); Great Vessel Perforation (2152); Iatrogenic Source (2498)
Date of Event	11/02/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient weight was not available from the site.The lot# of the device was not available from the site as they discarded all devices after the case and the philips representative was not at the case.The expiration date is also unavailable as it is determined by the lot#.Device manufactured date cannot be determined as the lot# is unavailable.The device was disposed of after the case.There is no allegation that the spectranetics/philips device caused/contributed to the event.
Event or Problem Description
On (b)(6) 2018, a cardiac lead management procedure for the removal of 2 leads (1 right atrial and 1 right ventricular) due to bacteremia was performed.A spectranetics 13fr tightrail rotating dilator sheath 545-513 was being used when a small tear less than 1cm in the patient's superior portion of their superior vena cava (svc) was noted.Rescue efforts were implemented and emergent sternotomy was performed.The patient survived the procedure.However, the patient¿s family removed the patient from life support on (b)(6) 2018.
Additional Manufacturer Narrative
Additional information received via phone conversation with manufacturer's representative regarding this event; this information is populated.Additional patient code added.
Event or Problem Description
Additional information: post market surveillance analyst spoke by phone with manufacturer's representative on (b)(4) 2018, who was not present at this procedure, to inquire if there were additional circumstances surrounding patient's death, since the reported svc (superior vena cava) injury was reportedly repaired.Representative stated that he had heard, subsequent to complaint submission, that the patient had an azygos injury instead, and emailed the physician for further information as to the details of the event.This additional information was not available and reportedly will not be provided to manufacturer.
Additional Manufacturer Narrative
Additional case detail provided by user facility.Relevant history/medical conditions provided by user facility.Spectranetics lead locking device added as concomitant medical product patient codes added.
Event or Problem Description
On december 27, 2018, the manufacturer received additional information from the facility via email, providing additional details of this event.There was no alleged reported malfunction of any spectranetics devices in use during the event.The facility director of cardiology reported the patient sustained only an azygos tear, and not an svc tear as initially reported.The two leads planned for extraction were a right atrial (ra) and right ventricular (rv) lead.Both leads reportedly contained spectranetics lead locking devices being used for traction platforms.Only the rv lead was extracted during the case; the ra lead was not extracted; it was abandoned due to case complexity.The suspected cause of the injury was reportedly a combination of the spectranetics tightrail device and pulling forces (spectranetics lld) that were both in use at the time of the event.The model and lot numbers of the lld device present in the rv lead are not available.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: TIGHTRAIL
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8120618
• Report Number: 1721279-2018-00164
• Device Sequence Number: 197559
• Product Code: DRE
• UDI-Device Identifier: 00813132020897
• UDI-Public: 00813132020897
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150360
• 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,Followup,Followup
• Report Date (Section B): 11/05/2018
• 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 Model Number: 545-513
• Device Catalogue Number: 545-513
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 12/13/2018; 12/27/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 12/19/2018; 01/22/2019
• 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; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005