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

Model Number	545-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Iatrogenic Source (2498); Pericardial Effusion (3271)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8965146
• Report Number: 1721279-2019-00154
• Device Sequence Number: 14220472
• Product Code: DRB
• UDI-Device Identifier: 00813132020897
• UDI-Public: 00813132020897
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019
• Report Date (Section F): 01/01/2005

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?: No
• Operator of Device: 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC 4076 ICD LEAD; MEDTRONIC 4195 ICD LEAD; MEDTRONIC 6935 ICD LEAD; MEDTRONIC 4076 ICD LEAD; MEDTRONIC 4195 ICD LEAD; MEDTRONIC 6935 ICD LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005