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

Model Number 545-513

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Iatrogenic Source (2498); Pericardial Effusion (3271)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight is unavailable from the facility.Device lot number and expiration date are not available from the facility.The device was discarded by the user.Device manufacture date is dependent on the device lot number, thus is unavailable.The device was discarded.There is no allegation of a malfunction.Therefore, no device evaluation will be performed.

Event Description

On (b)(6) 2019, a cardiac lead management procedure commenced to remove 3 leads due to infection.The patient had a biventricular icd, the leads were 4076 in the right atrium (ra), a 6935 in the right ventricle (rv), and a 4195 starfix lead in the left ventricle (lv).Leads were implanted on (b)(6) 2010, (b)(6) 2018, and (b)(6) 2012 respectively.The physician utilized a spectranetics tightrail rotating dilator sheath while attempting to remove the starfix lead, and then the patient's blood pressure dropped.There appeared to be an effusion.A sternotomy was performed.Rescue efforts were successful.All leads were removed.On (b)(6) 2019 the physician reported that a coronary sinus tear occurred and patient needed surgical intervention to repair.He also said it was unrelated to the use of the spectranetics tightrail device.

Manufacturer Narrative

Section d & g5) suspect device is being changed to lead locking device ez as this device was used as the traction platform, and is more likely to have caused/contributed to the reported injury.Device model #, lot#, di#, expiration date, and manufactured date are unavailable.

• 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: 8965146
• MDR Text Key: 156609027
• Report Number: 1721279-2019-00154
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132020897
• UDI-Public: 00813132020897
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/13/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Was Device Available for Evaluation?: No
• 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: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 4076 ICD LEAD; MEDTRONIC 4195 ICD LEAD; MEDTRONIC 6935 ICD LEAD; MEDTRONIC 4076 ICD LEAD; MEDTRONIC 4195 ICD LEAD; MEDTRONIC 6935 ICD LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR