MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS GLIDELIGHT LASER SHEATH; 16F GLIDELIGHT

Model Number 500-303

Device Problem Physical Resistance (2578)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Cardiac Perforation (2513)

Event Date 12/26/2013

Event Type  Injury  

Event Description

This was a lead extraction case to remove one fractured, non-functional lead.An lld-ez was used to prep the lead (medtronic 6949 rv icd).A 16f glidelight was used due to expected increased calcification on the 10 year old lead.Minor resistance in the area of the clavicle was encountered and then smooth lasing with sturdy traction was used all the way to the distal tip of the lead.The lead was removed successfully with counter-traction and a new rv lead was re-implanted.It was at this time that a drop in the patient's blood pressure was noted.A sternotomy was performed and an innominate-svc tear was discovered and repaired with sutures.The patient survived the intervention.

• Brand Name: SPECTRANETICS GLIDELIGHT LASER SHEATH
• Type of Device: 16F GLIDELIGHT
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: jessica hearn bsn, rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 3551819
• MDR Text Key: 4102472
• Report Number: 1721279-2013-00215
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/26/2013

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: Physician
• Device Expiration Date: 10/25/2015
• Device Model Number: 500-303
• Device Catalogue Number: 500-303
• Device Lot Number: FGC13K25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2013
• Initial Date FDA Received: 01/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ; SPECTRANETICS EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 71