MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD-EZ

Model Number 518-062

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Injury (2348); Fibrosis (3167)

Event Date 09/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This was a left-sided lead extraction procedure to remove three cardiac leads due to cied system/pocket infection and a class ii indication (bsc fidelis lv lead 4555, implanted 96 months, trending increase in svc impedance).The leads were prepped with llds and a cook bulldog lead extender was also used.A 14f glidelight and medium visisheath were used to extract.The rv lead (bsc 4472 fineline, implanted 96 months) was extracted successfully.During extraction of the lv lead, moderate fibrosis was noted in the innominate/svc area that required the laser sheath.The visisheath was used for support and was not advanced past the laser sheath.The laser was then advanced down to the svc/ra junction where heavy fibrosis was noted.After advancing through this area, the tip of the lv lead dislodged from the cs.At this time, the patient experienced a sudden drop in blood pressure.The ct surgeon was called for and chest compressions were initiated immediately.A sternotomy was performed and an injury to the svc/ra junction was discovered and repaired.The patient survived the intervention.The 3rd lead (bsc 0185 rv lead, implanted 96 months) was extracted manually during the open procedure.

Manufacturer Narrative

This report is being submitted to report that the suspect device in this case has changed.After further investigation by the sales rep and after discussing this event further with the physician, the suspect device has been changed from a glidelight to an lld.The physician stated that he believes the injury occurred when the laser sheath was advanced over a binding site proximal to the injury and the lead pulled at the next binding site, therefore tearing the svc/ra junction where it was attached.The physician believes he was pulling more than necessary and it was not a direct laser sheath injury.As the lld was the traction platform being used to pull on the lead, it is the suspect device 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-EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 5082719
• MDR Text Key: 25998264
• Report Number: 1721279-2015-00145
• 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: Followup,Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/02/2017
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2015
• 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: 55 YR