MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-062

Device Problem Malposition of Device (2616)

Patient Problems Low Blood Pressure/ Hypotension (1914); Injury (2348)

Event Date 05/31/2017

Event Type  Injury  

Event Description

During a lead extraction procedure to remove an ra and rv lead, an svc tear occurred.Reportedly, both leads were prepped with llds and the physician began with a 14f glidelight on the ra lead until progress stalled.He then moved to the rv lead, and progress stalled.The surgeon switched to the use of an 11f tightrail on the ra lead, and progress stalled.Moved to the rv lead and progress stalled.The 16f glidelight was then used on the rv lead and blood pressure dropped from the 70''s down to the 40''s.The bridge device was deployed and pressure stabilized for a couple of minutes.It is thought that the balloon moved, because the pressure then dropped a second time.At this point, the bridge device was removed and a sternotomy was performed.A 5cm tear to the svc was identified and successfully repaired.The leads (with llds) were cut and capped.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6660375
• MDR Text Key: 78176558
• Report Number: 1721279-2017-00120
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/21/2018
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP16D21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2016
• 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: MEDTRONIC ICD LEAD 5947 (IMPL 140MO); MEDTRONIC PACING LEAD 4568 (IMPL 170MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 26 YR
• Patient Weight: 76