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

Model Number 518-039

Device Problems Calcified (1077); Difficult to Remove (1528); Material Too Rigid or Stiff (1544)

Patient Problems Low Blood Pressure/ Hypotension (1914); 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, 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 patient's pressure normalized and the rv lead was removed.It was decided to discontinue the extraction.The lld was left because it would not unlock and was well seated in the lead lumen.The leads were successfully removed 36 hours later.Based on spectranetics guidelines the contact duration for this device is limited to 48 hours and has not been tested as an implantable device.Lld abandonment is not recommended by spectranetics due to the possibility of vessel or endocardial wall damage from the stiffened lead, fracture of the lld, or migration of the device.These devices were removed within the specified timeframe to reduce bioburden.

• 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: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 5919056
• MDR Text Key: 54400652
• Report Number: 1721279-2016-00113
• 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
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/24/2018
• Device Model Number: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: FLP16E24A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 50