MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD #2

Model Number 518-019

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 04/28/2015

Event Type  Injury  

Event Description

This was a left-sided lead extraction to remove one bsc dual coil icd lead (model # 0185, implanted 75 months) due to malfunction.The lead was prepped with an lld #2.A 14f glidelight laser sheath was opened and used for about 35 seconds of lase time.It was then decided to upsize to a 16f glidelight which was used for 145 seconds with successful removal of the icd lead.Within 30 seconds of lead removal, the patient became hypotensive.Tte showed a small pericardial effusion not present prior to the procedure (location of injury was the rv apex).The extractor used a pericardiocentesis kit to remove ~200-250 cc of blood.The patient was stabilized and monitored by the ep physician, staff, rn team, cv surgeon, and anesthesia.The patient was sent to recovery.Six days later, on (b)(6) 2015, the patient expired due to complications with anesthesia.This event is being reported with the lld as the suspect device as it was the traction platform being used to pull the lead free from the myocardium.

Manufacturer Narrative

Placeholder.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD #2
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION
• Manufacturer Contact: jessica hearn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4760295
• MDR Text Key: 16307416
• Report Number: 1721279-2015-00077
• 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: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: UNKNOWN
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• 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: BSC 0185 DUAL COIL ICD LEAD (IMPL 75 MON); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 99