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

Model Number 518-039

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226)

Event Date 03/09/2016

Event Type  Death  

Event Description

This patient had recently been diagnosed with cancer.A cardiac mri was needed and could not be done with these leads in place.A lead extraction was indicated to remove leads from the ra and the rv.Initially, cautery was used to free up the generator from the pocket.Both leads were prepped with lead locking devices.Lasing began and the rv lead was extracted by the physician pulling the lead into the laser as it started to retract.Once the lead was removed, the patients bp began to drop.A subclavian venogram demonstrated no svc tear.An intracardiac ultrasound was performed which revealed a cardiac tamponade.The patient was initially treated with inotropic agents and bp medications.Upon arrival of the surgeon the chest was opened and found a perforation in the anterior wall next to the septum where the icd lead had been "parked".The patient was placed on bypass.The remaining ra lead was lased out.Bleeding was controlled using a purse string suture and the perforation was surgically repaired.However, the patient expired on (b)(6) 2016.Due to the patients injury location at the anterior wall of the septum where it was reported the icd lead had been parked and the injury occurred after removal of the lead while the physician was pulling the lead with the lld inside indicates the lld may have caused or contributed to the injury.

Manufacturer Narrative

Updated to include device and patient codes.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 5543845
• MDR Text Key: 41758793
• Report Number: 1721279-2016-00045
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

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: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2017
• 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: CARDIAC LEAD MDT 6947 (IMP 105 MOS.)
• Patient Outcome(s): Death
• Patient Age: 61 YR