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

Model Number 518-062

Device Problems Mechanical Problem (1384); Material Separation (1562); Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The user facility did not return the device due to exposure to the patient's blood.

Event Description

A philips representative reported that a cardiac lead management procedure commenced.Two infected pacemaker leads were to be extracted, (1 right ventricular (rv), 1 right atrial(ra)), using the spectranetics lead locking device (lld) ez and the spectranetics 11fr tightrail rotating dilator sheath.Both infected leads were prepared with an lld-ez.When the physician was applying traction on the leads, the lld-ezs slipped back in both the leads to the superior vena cava (svc) and then further back to the subclavian region.The lld-ez within the rv lead broke and came out of the lead while the doctor was using the tightrail on the leads to cut adhesions over the leads.They then used a third lld-ez to prepare the lead again, it went well inside the lead until the apex, but upon applying traction at this point, the third lld-ez slipped back to svc and then to the subclavian region.This report is being submitted for the lld in use within the rv lead, which snapped and slipped back.(please see 1721279-2019-00152 and 1721279-2019-00153 submitted for the other llds in use.) the physician was unable to extract the infected leads with the llds.The procedure was abandoned and the patient was referred the cardio-thoracic vascular surgery team for open heart surgery to remove the infected leads.

Manufacturer Narrative

Date manufacturer became aware of event corrected to 07aug2019.

Manufacturer Narrative

D10): device returned for evaluation on (b)(6) 2019.H6): methods, results and conclusions codes now populated after device evaluation completed.Device evaluation: the device was returned and evaluated by a cross functional team on (b)(6) 2019.The team confirmed the inner coils (from the right ventricular lead) were present at the distal end of the portion of the lead locking device (lld) that was returned for evaluation.During evaluation, the braid of the lld was confirmed to be broken, approximately 34 cm from the proximal connector.The tip of the lld was not attached to the portion of the lld that was returned for evaluation.The team confirmed that the tip of the lld inverted with traction forces, causing the braid strands of the lld to fold over onto itself, eventually compromising and breaking the braid strand of the lld in that area.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8965067
• MDR Text Key: 156607443
• Report Number: 1721279-2019-00151
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLK19B13A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PACEMAKER LEAD (UNKNOWN MANUFACTURER/MODEL); SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; PACEMAKER LEAD (UNKNOWN MANUFACTURER/MODEL); SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 68