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

Model Number UNAVAILABLE

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

Patient Problems Iatrogenic Source (2498); Pericardial Effusion (3271)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

Information requested three times but not obtained.Patient date of birth unavailable.Patient age unavailable.Patient gender unavailable.Patient weight unavailable.Relevant test/laboratory data unavailable.Relevant history/preexisting medical conditions.Device model number, lot number, expiration date and udi unavailable.510k number unavailable because model number unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to infection.A spectranetics lead locking device (lld) was inserted into the rv lead to act as a traction platform in the extraction attempt.Per report, the extraction was successful.However, 10 minutes after extraction was completed, the patient's blood pressure dropped and a pericardial effusion was discovered.The physician inserted a pigtail catheter and drain; these rescue efforts were successful, no sternotomy was required and the patient survived.Another rv lead was not re-implanted due to the patient's infection.The physician suspects there was a small effusion potentially at the apex of the heart.It was reported that the injury may have been small perforation where the rv lead was implanted.No other spectranetics tools were in use in the suspected area of injury.This report is being submitted because the lld was present in the distal tip of the rv lead which was removed, and could have caused/contributed to the effusion in the suspected area of injury (apex).

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• 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: 10080275
• MDR Text Key: 196082941
• Report Number: 1721279-2020-00107
• 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: 01/01/2005,04/27/2020

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 Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• 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: 04/27/2020
• Initial Date FDA Received: 05/21/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention