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

Model Number 518-062

Device Problems Break (1069); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Staphylococcus Aureus (2058); Low Oxygen Saturation (2477)

Event Date 07/13/2015

Event Type  Death  

Event Description

Lead management case to extract three leads due to a pocket infection that was positive for staph aureus, finegoldia manga and staph haemolyticus.The patient was prepped for emergency access and a capsulectomy was performed exposing the proximal leads.All leads were previously cut so the active fixation of the ra lead was not able to be disengaged (the two rv leads were passive fixation).All three leads were prepped with lld ez locking stylets with the insulation secured by suture.A 14f glidelight was passed over one of the rv leads (unable to tell which).The 14f glidelight was able to reach the distal innominate vein.Lasing stopped after two attempts to cross the lesion without progress.The physician then switched to the other rv lead with the exact same result.Again the physician switched leads moving to the ra lead.At this time the physician was able to advance the laser sheath to the fixation helix.The ra helix was firmly attached to the septal wall of the ra and was unable to be removed with traction alone.At this time the lld in this lead broke.The physician used a suture to then extend the traction platform and an ev 3 amplatz gooseneck snare was slid over the lead; before reaching the lead tip the lead released.A large asd was caused with left to right shunting as evidenced on echo.The cvp and blood pressure remained stable without evidence of effusion.The physician then returned to one of the rv leads using the 14f glidelight and was able to extract the lead without evidence of complication.The physician then advanced the 14f glidelight down the final rv lead to the distal tip.Traction was applied to the lead and a marked drop in blood pressure and oxygen saturation occurred.The anesthesiologist noted the large asd and atrial fibrillation but was unable to identify an effusion.Contrast injection through the ij also did not reveal a perforation.Medications were given to stabilize the patient but ultimately would not return to baseline.The physician felt as though there may still be tension on the remaining lead and worked to relieve that but the patient¿s blood pressure dropped again.Chest compressions were started while the physician attempted a fem/fem bypass.After several failed attempts to obtain bypass compressions ceased as the patient was a dnr.This adverse event is being reported on the lld as it was used as the traction forces inside of the leads; although the physicians were unable to determine an injury location the physicians believed that the injury was likely in the rv apex and resulted during traction.

Manufacturer Narrative

(b)(4).

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 EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 4913991
• MDR Text Key: 6011491
• Report Number: 1721279-2015-00107
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/10/2017
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP15C10A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2015
• 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 TORQMAX SHEATH GRIP ACCES.; GDT 4554 RA CARDIAC LEAD (IMPL. 72MO); SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; GDT 0157 RV CARDIAC LEAD (IMPL. 72MO); SPECTRANETICS VISISHEATH DILATOR SHEATH; MDT 4557 RV CARDIAC LEAD (IMPL. 185MO); SPECTRANETICS LEAD LOCKING DEVICE (X2)
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Weight: 88