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

Model Number UNAVAILABLE

Device Problem Device Inoperable (1663)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

Patient date of birth and age unavailable; patient weight unavailable; device model, lot, expiration date and udi unavailable; manufacture date unavailable.

Event Description

During a planned lead extraction using an lld and an 11f tightrail device, the physician noticed extremely heavy calcification.While attempting extraction, he noticed that the cutting system of the tr did not work anymore.Due to the heavy calcification, he stopped the lead extraction procedure and scheduled a thoracotomy two days later, where the leads were successfully extracted.Lld's were left inside the ra and rv lead.Patient survived procedure.This report represents the ra lead that was cut and capped.

• Brand Name: SPECTRANETICS 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: 6954675
• MDR Text Key: 89490866
• Report Number: 1721279-2017-00234
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• 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: 09/25/2017
• 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
• Treatment: SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS LEAD LOCKING DEVICE
• Patient Outcome(s): Hospitalization; Other; Required Intervention