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

Model Number 518-062

Device Problem Difficult to Remove (1528)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Tissue Damage (2104); Injury (2348)

Event Date 03/08/2017

Event Type  Death  

Manufacturer Narrative

Patient weight is not available from the facility.Device lot number and expiration date are not available from the facility.The device was discarded by the user.Device manufacture date is dependent on the device lot number, thus is unavailable.

Event Description

It was reported that during a lead extraction procedure to remove two 15 year old leads, a tear to the rv apex occurred.Reportedly, the patient presented with a pocket infection and erosion of the device.The first lead (cs lead) was successfully removed with the use of a glidelight and a tightrail device.When attempting to remove the rv icd lead, the laser was used but never entered the heart.When the physician pulled on the lld device (being used for traction) and the lead, it came free with a large portion of heart tissue.Blood pressure dropped at this point, a sternotomy was performed, and the patient was placed on bypass.However, the patient did not survive this intervention.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• 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: jason hearn ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-236
• MDR Report Key: 6440819
• MDR Text Key: 71102159
• Report Number: 1721279-2017-00057
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• 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,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• 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: MEDTRONIC ICD LEAD 6947 (IMPL 181MO); MEDTRONIC PACING LEAD 2187 (IMPL 181MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Death
• Patient Age: 78 YR