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

Model Number 518-019

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Iatrogenic Source (2498); Pericardial Effusion (3271)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

Patient weight was not available from the site.The lot# was unavailable from the site.Device expiration date is determined by lot# and is therefore also unavailable.Device manufacture date is unavailable as the lot# could not be obtained.Device was discarded by the site.There is no allegation of a malfunction of the device.Therefore, no evaluation will be performed.

Event Description

A philips representative reported that during a cardiac lead management procedure to remove a non-functional atrial lead, a spectranetics lead locking device 518-019 was utilized.The patient's blood pressure dropped after the procedure and anesthesia detected by transesophageal echocardiogram (tee) that there was an effusion near the atrium and pericardial sack.Interventional cardiology was called and they placed a drain.About 400 cc of blood was drained from the heart.The drain was left in place.Patient did not require a blood transfusion.Patient survived the procedure, was extubated, and placed in the intensive care unit (icu) overnight.

• Brand Name: SEPCTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8158082
• MDR Text Key: 130215155
• Report Number: 1721279-2018-00172
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: 00813132023010
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K990713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,11/19/2018

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
• Device Operator: Health Professional
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• 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: 11/19/2018
• Initial Date FDA Received: 12/12/2018
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 84 YR