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

Model Number UNAVAILABLE

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

Patient Problem Death (1802)

Event Date 10/13/2020

Event Type  Death  

Manufacturer Narrative

Patient weight unavailable.Device model number, lot number, expiration date and udi unavailable.Device 510k number unavailable because model number unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove three leads: a right ventricular (rv), right atrial (ra) and left ventricular (lv) lead due to bacteremia.Prior to the procedure, the patient had a do not resuscitate (dnr) order in place.It was reported that when the patient was put under general anesthesia, his blood pressure dropped immediately and was treated with medication, with the blood pressure returning to normal level.The extraction of the three leads was successful.However, 7-8 minutes after the last lead was removed (which was the ra lead), the patient's blood pressure dropped again.Medication and other diagnostics were performed to detect the cause of the blood pressure drop to no avail.The patient's blood pressure did not return and the patient passed away.Although the physician was uncertain, it was suspected that the cause was due to an ischemic issue.However, a pulmonary embolism or perhaps bleeding from the right atrium could not be ruled out.This report is being submitted because a spectranetics lead locking device (lld) was present within the ra lead, which was the last lead to be removed prior to the patient's drop in blood pressure.There was no alleged malfunction of any spectranetics device in use during 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: 10818877
• MDR Text Key: 215639424
• Report Number: 1721279-2020-00228
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 10/13/2020

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 Model Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC 4136 RA PACING LEAD; BOSTON SCIENTIFIC 4137 RV PACING LEAD; BOSTON SCIENTIFIC 4674 LV LEAD; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Death
• Patient Age: 89 YR