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

Model Number 518-062

Device Problems Fracture (1260); Device Handling Problem (3265)

Patient Problems Low Blood Pressure/ Hypotension (1914); Scarring (2061); Injury (2348)

Event Date 03/17/2016

Event Type  Injury  

Event Description

A (b)(6) male presented for extraction of four cardiac leads due to various issues with the current leads, and to have re-implantation of upgraded leads all coming from a left side generator placement.Lead locking devices were used to prep all four leads.A lead that had been implanted via a right sided generator was extracted from the rv, as the physician wanted all new leads coming from a generator implanted on the left.The next lead was extracted from the ra due to fracturing, and then another rv lead was removed that had been cut and capped.No issues during removal of the first three leads.The lv lead had been recalled and was attempted to be removed using a 12 fr.Glidelight, the physician up-sized to a 14 fr.Glidelight because he needed something more robust to get through the heavy scarring.He progressed smoothly and stopped use of the glidelight at the coronary sinus.The physician held steady traction without freeing the lead.He gave a firm pull on the lead and it came free.Approximately two minutes after the lead was removed, the patient's blood pressure dropped.The surgeon was scrubbed in during the lead extraction and performed a pericardiocentesis, this did not solve the issue.The anesthesiologist did a tee and determined there was blood filling the cs.A pericardial window was done without success.Sternotomy was performed and an injury at the obtuse marginal vein, adjacent to the cs was found and repaired.Per the spnc representative, physician stated he pulled too hard as the hole was located where the lead had been attached.Three new leads were placed and the patient survived the procedure.This report is being made against the lld as it was used as the traction platform from removal of the 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 dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 5564964
• MDR Text Key: 42410965
• Report Number: 1721279-2016-00050
• 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: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• 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
• Device Lot Number: UNKNOWN
• 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
• 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: 114