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

Model Number 518-062

Device Problems Break (1069); Material Perforation (2205); Positioning Problem (3009)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

This was a right-sided lead extraction procedure to remove two cardiac leads due to cied pocket infection.The ra epicardial lead was extracted using an lld-ez and a 14f glidelight.It was noted during the extraction of the ra lead that there was difficulty progressing with the glidelight in the area of the subclavian and svc junction.This difficulty was also noted during the extraction of the rv lead.Higher settings (fluence and rate) were used in this area, however the glidelight was not able to get through.The glidelight was then removed and it was noted that the laser sheath was damaged (red light was visible through the sheath).The physician then used a cook evolution mechanical sheath, however it was not able to progress through the same area.It was noted at this time that the patient began to bleed, however the physician did not believe it to be urgent.Another 14f glidelight was used, however there was difficulty progressing in the same area again.Upon removal of the catheter, damage to the outer insulation was noted again (similar to first glidelight).The patient began to bleed more heavily and a sternotomy was performed.Two holes in the subclavian vein were found and repaired.Due to the complexity of the case and the injury that occurred, the physician elected to cut and cap the ra lead and abandon the lld inside the lead.The plan is to perform another lead extraction via a femoral approach at a later date to extract the abandoned lead and lld.The patient stabilized and was sent to recovery following the procedure.This report is being filed for the lld requiring situational abandonment inside the patient's vasculature.

Manufacturer Narrative

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Manufacturer Narrative

New information regarding this event received and updated in this file, including: patient's date of birth and age; patient's medical history / co-morbidities; lead information.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD-EZ
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: jessica hearn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4481588
• MDR Text Key: 5563626
• Report Number: 1721279-2015-00021
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2015

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 Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• Other Device ID Number: PARTIAL: M2045180620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 02/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: RV ICD (INFORMATION UNKNOWN); MEDTRONIC 4076 RA EPICARDIAL LEAD (IMPL 56 MON); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; MEDTRONIC 6935 RV ICD LEAD (IMPL 56 MON); SPECTRANETICS LEAD LOCKING DEVICE; RA EPICARDIAL LEAD (INFORMATION UNKNOWN); 14F GLIDELIGHT LASER SHEATH X2; COOK EVOLUTION MECHANICAL DILATOR SHEATH
• Patient Outcome(s): Other
• Patient Age: 63 YR