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

Model Number UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Perforation (2001); Pericardial Effusion (3271)

Event Date 02/03/2017

Event Type  Death  

Manufacturer Narrative

Associated mdr #: 1721279-2017-00031.

Event Description

Lead management case to extract 3 cardiac leads due to bacteremia.The younger rv lead was removed without incident using a 16f glidelight laser sheath.During removal of the ra lead, a 14f glidelight laser sheath was used; however during this extraction, a slight drop in blood pressure was noted.The other rv lead was attempted to be extracted with the 14f glidelight, upon reaching the tricuspid valve, severe calcification was encountered, so the device was upsized to a 16f glidelight.Upon further review of the rv lead tip on fluoroscopy, it appeared that it may have been placed deeper into the rv apex than usual when implantated.When the rv lead was removed, an effusion occurred.A bridge balloon was placed and a sternotomy was performed.The surgeon identified a 2-3cm svc tear and an rv perforation.Due to patient condition and comorbidities, it was not possible to rescue the patient.Two adverse events will be reported regarding this clinical case.This report will report on the lld used in this case; it likely contributed to the rv tear as it was the traction platform used to pull the lead tip from the myocardium.Mdr# 1721279-2017-00031 will contain details on the 14f laser sheath in use when the blood pressure dropped; this device was the device in use at the svc area and likely resulted in the svc tear.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 6366673
• MDR Text Key: 68594446
• Report Number: 1721279-2017-00032
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K43401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2017
• 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 CARDIAC LEAD (IMPL. 171MO); MDT 4568 CARDIAC LEAD (IMPL. 199MO); MDT 5068 CARDIAC LEAD (IMPL. 199MO); SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Weight: 61