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

Model Number 518-062

Device Problems Positioning Problem (3009); Scratched Material (3020)

Patient Problems Low Blood Pressure/ Hypotension (1914); Excessive Tear Production (2235)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

Lead management case to extract two cardiac leads during a gen change.The first lead was a 1581 riata (impl.(b)(6) 2006 in the rv), due to exposed cables the decision was made to use a 16f glidelight for extraction.An lld ez was used to prep the lead and lasing began with the glidelight.The glidelight was moving slowly and smoothly with no indication of a complication, upon entering the ra progress was halted and it was noticed under fluoroscopy that the lead started to bunch up.A little more progress was attempted before deciding to change over to the ra lead (sjm ventratek model number unknown implanted (b)(6) 2006) when the blood pressure dropped.The surgeon immediately performed a sternotomy and on examination of the site it was discovered that the entire innominate was torn.It was believed by the physician that the lead had been extra-cardiac providing an externalized track for the glidelight to follow causing the tear.The innominate injury was repaired and extraction attempts were stopped for fear of causing the vessel to tear further.The lld ez was cut and capped within the lead.The patient survived intervention.This report is to reflect the abandonment of the lld ez.

Manufacturer Narrative

Report for the glidelight is mdr report 1721279-2014-00095.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD EZ
• Manufacturer (Section D): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: sondra chandler rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472530
• MDR Report Key: 3873527
• MDR Text Key: 4569282
• Report Number: 1721279-2014-00096
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• 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: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/14/2016
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP14A14A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2014
• 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 CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SJM 1581 RIATA CARDIAC LEAD (IMPL. (B)(6) 2006); SJM VENTRATEK (UNK MODEL # IMPL. (B)(6) 2006)
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 88