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

Model Number 518-062

Device Problem Mechanical Problem (1384)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 10/19/2019

Event Type  Injury  

Manufacturer Narrative

Device expiration date is unknown because device lot number is unavailable device manufacture date is unknown because device lot number is unavailable.

Event Description

A lead extraction procedure commenced to remove three leads: a right ventricular(rv), a right atrial (ra) and a previously capped left ventricular (lv) lead due to non function.In addition, a functional lv lead was also present, and was not targeted for extraction.With use of spectranetics 14f and 16f glide light devices along with lead locking devices (lld's)to be used to apply traction on the leads, the physician encountered heavy scarring on the ra and rv leads which required the physician to switch back and forth in extraction attempts, between leads and 14f and 16f glide light laser sheaths.With no significant progress being made beyond the superior vena cava (svc), the physician then switched to use of a spectranetics 11f tight rail device to attempt removal of the rv lead.It was reported that the md didn't pull device handle to engage the blades of the tight rail device; instead, she gently pushed the device to the svc, to the point of prior stalled progression.The patient's blood pressure drastically and suddenly declined.Rescue efforts commenced immediately, including rescue device and sternotomy.A 2 mm tear was discovered in the svc.This injury was successfully repaired while the patient was on bypass.It was reported the patient is recovering well (please refer to mdr 1721279-2019-00194 which was submitted to capture the svc injury).The ra, rv and lv leads targeted for removal were capped, with an lld remaining in each lead, and were not removed from the patient.The physician attempted to unlock the lld's to remove them prior to capping the leads, but was unsuccessful.This report is submitted to capture the rv lead and lld which was cut and capped and left in the patient's body.The physician has been reminded via a letter that the lld is not intended for implantation.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9318009
• MDR Text Key: 166528051
• Report Number: 1721279-2019-00196
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• 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: 01/01/2005,10/19/2019

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?: Yes
• Device Operator: Health Professional
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/19/2019
• Initial Date FDA Received: 11/13/2019
• 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): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 68