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

Model Number UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bacterial Infection (1735); Low Blood Pressure/ Hypotension (1914); Injury (2348); Cardiac Perforation (2513)

Event Date 08/09/2016

Event Type  Injury  

Event Description

Lead management cardiac lead extraction case due to bacteremia.The 7120q was prepped and extracted with no issues.The 7120q was extracted with a 14f glidelight with 4 seconds of laser time.The 1581 was prepped and initially attempted to extract with the 14f glidelight.After a little stalled progression, it was decided to upsize to a 16f glidelight.The lead then dislodge and was easily pulled through the laser sheath.The physician only lased for 13 seconds and never went past the innominate vein.Once the lead was extracted, a drop in pressure was noticed.The physician noticed a large fatty tissue at the end of the lead and he believed there was a perforation of the heart where the lead had been attached.He performed a sternotomy and found a hole in the rv.The hole was repaired and patient survived the intervention.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9945 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: 5928640
• MDR Text Key: 53933240
• Report Number: 1721279-2016-00115
• 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,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• 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: 03/03/2017
• 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: CARDIAC LEAD 1581; CARDIAC LEAD 7120Q; SPECTRANETICS 14F GLIDELIGHT; SPECTRANETICS 16F GLIDELIGHT; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 124