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

Model Number 540-011

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Iatrogenic Source (2498)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

Patient's weight was unavailable from the site.Lot # and expiration date could not be determined as the site discarded the device.Manufacture date could not be determined since the lot# is unavailable.Site discarded the device.Therefore, device evaluation cannot be completed.There is no allegation that the device malfunctioned.

Event Description

A philips representative reported that during a cardiac lead management procedure 5 leads were to be extracted.The physician utilized the 12fr glidelight laser sheath first, the 9fr long tightrail rotating dilator sheath second, and then an 11fr tightrail mini rotating dilator sheath 540-011 with a lead locking device (lld).After the right atrium tendril lead was extracted utilizing the spectranetics tightrail mini 540-011, the patient's blood pressure dropped significantly.An effusion was visible on imaging.There was an injury to the superior vena cava (svc)/right atrial (ra) junction.Rescue efforts commenced and were successful.Patient survived the procedure and all 5 leads intended for removal were successfully extracted.

Manufacturer Narrative

It was detected on (b)(6) 2018 that on the initial medical device report, was populated incorrectly as (b)(6) 2018, but should have been (b)(6) 2018.

• Brand Name: SPECTRANETICS TIGHTRAIL MINI ROTATING DILATOR SHEATH
• Type of Device: TIGHTRAIL
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7940904
• MDR Text Key: 123044741
• Report Number: 1721279-2018-00144
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132020866
• UDI-Public: 00813132020866
• Combination Product (y/n): Y
• PMA/PMN Number: K150360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/12/2018

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
• Device Operator: Health Professional
• Device Model Number: 540-011
• Device Catalogue Number: 540-011
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 10/08/2018
• Supplement Dates FDA Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS CVX-300 LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE (LLD); SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR