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

Model Number 518-039

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Discharge (2225); Cardiac Tamponade (2226)

Event Date 08/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This was a case to extract three cardiac leads due to bacteremia, cied system/pocket infection.Leads were prepped with spectranetics lead locking devices.The right ventricular lead was heavily calcified which caused stalled progress of the 14 fr.Glidelight laser sheath near the tricuspid valve.Counter traction was applied to the rv lead and it was noted that the lead felt stiff.At that time, the patient had a drop in blood pressure.The surgeon was notified and a fluoroscopy of the cardiac silhouette showed a cardiac tamponade.Cpr was initiated and one unit of blood given.Pericardiocentesis was done and 50 cc of blood removed.The patients' pressure normalized and the ra lead was removed.Lld is being reported as a contributory device as it was used to apply the traction forces.The patient survived the procedure.

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 dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 5921567
• MDR Text Key: 53743975
• Report Number: 1721279-2016-00111
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• 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,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/21/2018
• Device Model Number: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: FLJ15F12A
• 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
• Date Device Manufactured: 03/21/2016
• 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: CARDIAC LEAD BSC 4470 (IMPL. 88 MOS.); CARDIAC LEAD MDT 4195 (IMPL. 88 MOS.); CARDIAC LEAD MDT 6947 (IMPL. 88 MOS.); SPECTRANETICS CVX-300 LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 50