MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number 518-067

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

Patient Problems Death (1802); Thrombus (2101); Iatrogenic Source (2498); Cardiac Perforation (2513)

Event Date 07/22/2020

Event Type  Death  

Manufacturer Narrative

Patient weight unavailable.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to infection.Spectranetics lead locking devices (lld''s) were inserted into each lead to act as traction platforms to aid in lead extraction, and the physician chose a 10f cook dilator sheath for use as well.According to the report, the ra lead was successfully extracted.However, after the extraction of the rv lead, the patient's blood pressure dropped.An effusion and also a large thrombus in the rv were noted via transesophageal echocardiography (tee).Rescue efforts commenced immediately, including pericardiocentesis.400cc blood was evacuated but unfortunately the patient died after 1/2 hour of resuscitation.There was no alleged malfunction of the lld''s used in the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• 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: 10379043
• MDR Text Key: 202032814
• Report Number: 1721279-2020-00164
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: BE
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,07/22/2020

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 Expiration Date: 04/03/2022
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLK20C31A
• 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: 07/22/2020
• Initial Date FDA Received: 08/07/2020
• 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
• Treatment: 10F COOK DILATOR SHEATH; MEDTRONIC 4076-52 RA PACING LEAD; MEDTRONIC S 6935M-62CM RV ICD LEAD; SPECTRANETICS LEAD LOCKING DEVICE
• Patient Outcome(s): Death
• Patient Age: 74 YR