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

Model Number 518-062

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

Patient Problems Calcium Deposits/Calcification (1758); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Pericardial Effusion (3271)

Event Date 10/06/2014

Event Type  Injury  

Event Description

This was a lead extraction case performed in the cath lab to remove 4 leads due to cied system infection.The physician was attempting to remove a previously abandoned ra lead (sjm 1342t, implanted in 1998 and capped/abandoned in 2004).The physician encountered calcification in the svc innominate/svc area.He stopped lasing and began to manually dissect the binding sight with the use of the laser catheter and outer sheath.The blood pressure dropped and the anesthesiologist noticed excess fluid in the pericardium via tee.The ct surgeon was called into the room and a pericardial window and pericardiocentesis to drain the pericardial sack was performed.A chest tube was put into the patient and the procedure was aborted.This report is being filed as an lld was left inside the ra lead when it was cut and capped.

Event Description

This was a lead extraction case performed in the cath lab to remove 4 leads due to cied system infection.The physician was attempting to remove a previously abandoned ra lead (sjm 1342t, implanted in 1998 and capped/abandoned in 2004).The physician encountered calcification in the svc innominate/svc area.He stopped lasing and began to manually dissect the binding sight with the use of the laser catheter and outer sheath.The blood pressure dropped and the anesthesiologist noticed excess fluid in the pericardium via tee.The ct surgeon was called into the room and a pericardial window and pericardiocentesis to drain the pericardial sack was performed.A chest tube was put into the patient and the procedure was aborted.This report is being filed as an lld was left inside a lead when it was cut and capped.

Manufacturer Narrative

Added weight, relevant tests, relevant history.Corrected concomitant from spectranetics lld to spectranetics lld-ez.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD-EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: linda todd ; 9965 federal drive; colorado springs, CO 80921 ; 7194472567
• MDR Report Key: 4182920
• MDR Text Key: 5024217
• Report Number: 1721279-2014-00178
• 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,Followup
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/05/2016
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP14B04A
• Other Device ID Number: M204518062058010216FLP14B04A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2014
• Initial Date FDA Received: 10/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• 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: SJM 1688T CARDIAC LEAD (X2); CVX-300 EXCIMER LASER; SPECTRANETICS LLD; SJM 1346T CARDIAC LEAD; SPECTRANETICS LLD-EZ; SPECTRANETICS GLIDELIGHT LASER SHEATH; SJM 1342T CARDIAC LEAD
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 99