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

Model Number 518-062

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

Device lot number and expiration date not available.The device was discarded by the user.Device manufacture date is dependent on the device lot number, thus is unavailable.

Event Description

It was reported that during a lead management procedure to extract two pacemaker leads (ra and rv) due to infection, an effusion was identified.An lld device was used for traction in the removal of both leads.Reportedly, both leads were extracted using an sls laser sheath.After the rv lead was removed, the blood pressure dropped.No effusion was confirmed and the blood pressure increased with the administration of medication.Then the physician started to extract the ra lead.The sls device reached near the tip, and the lead was extracted.The blood pressure dropped and a small effusion was confirmed.The surgeon performed small incision at the ensiform cartilage and a drain tube was inserted.The patient outcome was good, with some additional hospitalization being required.This report pertains to the removal of the ra lead.

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
• 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 ; 719447-246
• MDR Report Key: 6425443
• MDR Text Key: 70622976
• Report Number: 1721279-2017-00052
• 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: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

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 Model Number: 518-062
• Device Catalogue Number: 518-062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/22/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 08/09/2017
• 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: BIOTRONIK FRASTE JT 45 ICD LEAD (IMPL 96MO); BIOTRONIK FRASTE ST 53 PACING LEAD (IMPL 96MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS SLS LASER SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 90 YR