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

Model Number 518-062

Device Problem Human-Device Interface Problem (2949)

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

Event Date 07/09/2015

Event Type  Injury  

Event Description

This was a right-sided lead extraction procedure to remove one ra lead (sjm 1474t, impl 135 months) and one rv lead (sjm 1452t, impl 135 months) due to infection.Both leads were prepped with lld-ezs.The physician started the extraction of ra lead using a 12f sls but the progress stopped, so he switched to the rv lead.When the 12f sls was inserted into the subclavian vein (no lasing), the patient¿s blood pressure decreased gradually to 60/30.There was no indication of an injury and the pressure increased on its own, so the procedure was continued.The device was progressed up to svc and stopped.A cook mechanical sheath was then used and it progressed to the right atrium.At that time, the rv lead came free.At this time, the patient¿s blood pressure declined again to 60/30 and a small effusion was confirmed using tee.A pericardiocentesis was performed and approximately 70cc of fluid was drained.The patient¿s blood pressure then increased to 100/50 after the intervention.The procedure was continued using a 12f sls ii on the ra lead with progression to the proximal coil.The physician then upsized to a 14f sls ii and the lead was extracted without any further issue.The patient recovered from the procedure and was discharged.It is not known where the injury was located.As the injury was able to be treated with a less invasive treatment and was not more severe in nature, it is highly suspect that the injury occurred as the lead pulled free from the myocardium (rv perforation).It is because of this that we are attributing the injury to the lld as it was the traction platform being used to pull the lead free from the myocardium.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

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 CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4932645
• MDR Text Key: 15839884
• Report Number: 1721279-2015-00110
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2015

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: 02/25/2017
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP15B25A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2015
• Initial Date FDA Received: 07/22/2015
• Supplement Dates Manufacturer Received: 08/17/2017
• Supplement Dates FDA Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2015
• 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 CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE (LLD-EZ); SPECTRANETICS 12F SLS II LASER SHEATH; SPECTRANETICS 14F SLS II LASER SHEATH; COOK MECHANICAL SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 84 YR