MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS LLD EZ LEAD LOCKING DEVICE

Model Number UNAVAILABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 11/20/2017

Event Type  Death  

Manufacturer Narrative

Device model, lot, expiration date and udi unavailable; device was discarded prior to obtaining information.Device manufacturing date unavailable.

Event Description

A lead extraction procedure was completed with various spnc devices in use, successfully removing one ra and one rv lead, due to infection.However, late during the night following the procedure, the patient went in rapid hemodynamic compromise and cardiogenic shock.A pericardiocentesis at bedside caused brief improvement of hemodynamic status; and then the patient was pulseless.Considering the length of poor hemodynamics, age, comorbid conditions and length of resuscitative measures, surgical intervention was not an option.Family chose not to have surgery to repair.Patient expired.Upon questioning the physician, it was felt that an injury occurred in the rv apex from the tip of the rv lead upon extraction.

• Brand Name: SPECTRANETICS LLD EZ LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 7115389
• MDR Text Key: 94791565
• Report Number: 1721279-2017-00288
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNAVAILABLE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• 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): Death
• Patient Age: 85 YR
• Patient Weight: 64