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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/22/2015

Event Type  Death  

Event Description

This case was a left sided lead extraction to remove 4 leads due to system/pocket infection.The lv lead (medtronic 4298 implanted 2 months) was removed with traction only.Stylets were placed in the 1994 ra (intermedics 432-03 implanted 240 months) and rv (lntermedics 430-07 implanted 240 months.) the 1998 ra lead (medtronic 4524 implanted 192 months) was prepped and locked with lld ez and 16fr gl was used to remove lead.Several minutes after the extraction there was a gradual decline in bp noted and a pericardial effusion was noted on tee.A pericardiocentesis was performed, as well as a sternotomy.A perforation of the right atrium was located and repaired, as well as an injury to the svc.The two remaining leads were removed (1994 ra & rv) during the open procedure.Unfortunately the patient did not survive.This report is reflecting the injury to the ra which was contributed to by the lld.The other injury, svc, was contributed to by the glidelight which will be submitted in another report.

Manufacturer Narrative

G5) 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; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 7194472210
• MDR Report Key: 4899312
• MDR Text Key: 6022225
• Report Number: 1721279-2015-00103
• 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: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• 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
• Other Device ID Number: UNKNOWN
• 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
• 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 GLIDELIGHT LASER SHEATH 16FR; GUIDANT 4136 TEMP PACEMAKER; INTERMEDICS 432-03 IMP 240MO. RA LEAD; STYLETS UNKNOWN MANUFACTURER X 2; MDT 4524 RA LEAD IMP 192 MO.; SPECTRANETICS CVX 300 EXCIMER LASER; INTERMEDICS 430-07 IMP 240 MO. RV LEAD; MDT 4298 IMP 3 MO. LV LEAD
• Patient Outcome(s): Death
• Patient Age: 57 YR
• Patient Weight: 83