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

Model Number 518-062

Device Problem Difficult to Remove (1528)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 04/07/2017

Event Type  Injury  

Manufacturer Narrative

Udi field not sufficient to display all digits, should read: (b)(4).

Event Description

It was reported that during a lead extraction procedure to remove a cardiac icd lead from the right ventricle (rv), a perforation in the cardiac tissue was identified.Reportedly, the lead had been prepped with a spectranetics lead locking device (lld) and an spectranetics laser sheath was used free the lead up to the point of the innominate/svc junction.Upon using traction, the lead was freed from the cardiac wall and a drop in blood pressure was noted.An effusion was identified by transesophageal echocardiogram (tee) and a sternotomy was performed.The 4 mm tear in the rv apex was repaired and the patient outcome was good.The patient was discharged from the icu two days post-procedure.

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: 6534767
• MDR Text Key: 74101166
• Report Number: 1721279-2017-00074
• 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
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/03/2018
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP16J28A
• 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: 09/28/2016
• 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 GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 81