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

Model Number 518-062

Device Problem Fracture (1260)

Patient Problems Low Blood Pressure/ Hypotension (1914); Injury (2348)

Event Date 12/11/2017

Event Type  Injury  

Event Description

It was reported that during a lead extraction procedure to remove a fractured right ventricular (rv) lead, a lead was cut and capped with an lld device within it.Reportedly, the lead was prepped with an lld device.A tightrail device was used to successfully navigate from the entry point of the left sided pocket through the innominate vein and into the superior vena cava (svc), and finally to the proximal end of the distal coil.Counter traction was then applied in order to release the lead from the ventricular apex.At this point the patient's blood pressure dropped.A sternotomy was performed to successfully repair a tear to the right atrium/ivc junction.The lead was cut and capped.The lld device remains within the lead.The patient recovered and the outcome was good.

• 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: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 7162642
• MDR Text Key: 96340958
• Report Number: 1721279-2018-00002
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/17/2019
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP17K13A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2017
• 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: 63 YR
• Patient Weight: 54