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

Model Number 518-062

Device Problem Retraction Problem (1536)

Patient Problems Bruise/Contusion (1754); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Perforation (2001); Tissue Damage (2104)

Event Date 05/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This was a case to remove a cardiac lead; sprint fidelis dual coil 6949-65cm due to cied system/pocket infection.The helix of the lead was unretractable.A spectranetics lead locking device was deployed on the lead and a 14fr glidelight was used to begin extraction of the lead.After lasing the proximal coil released from the svc and pulled free of the rv apex.Lead was removed.Tissue was noted on the tines of the lead commiserate with myocardium.The patient's blood pressure dropped and an effusion was detected via tee.The ct surgeon was notified and arrived to perform a sternotomy.A bruise was noted at the rv apex where the tissue had pulled out.The perforation appeared to have resolved as no active bleeding was noted.The surgeon placed a suture to safe-guard reopening of the wound.The patient survived the procedure.This report is being made against the lld as it was the traction platform used in this case.

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 blvd; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 5718846
• MDR Text Key: 47198489
• Report Number: 1721279-2016-00073
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/13/2016
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP14H13A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 91