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

Model Number 518-062

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problems Calcium Deposits/Calcification (1758); Hemorrhage/Bleeding (1888); Device Embedded In Tissue or Plaque (3165); Fibrosis (3167)

Event Date 06/18/2014

Event Type  Injury  

Event Description

Lead management case to extract two non-functional leads.The physician began the procedure by prepping each lead with an lld ez.Using a 14f glidelight with the teflon outer sheath the physician was able to make progress on the rv lead (6949 implanted 2004) to the proximal portion of the svc coil; primarily using aggressive mechanical dissection with the outer teflon sheath.No advancement could be made with the laser only and heavy fibrosis and calcium was noted in the pocket before lasing.After approximately 4 minutes the decision was made to upsize to a 16f glidelight and visisheath.The physician continued to manually dissect this time using the visisheath.While at the subclavian area a large amount of bleed back from the laser sheath was noted.An abg showed that the patient's hematocrit had dropped from 34 to 28, noted bleeding was noted on tee or fluoroscopy.Four units of prbcs were infused and the surgeon came in to stop the bleeding in the pocket, this intervention was successful and the patient recovered.Extraction of the two leads was halted at this time abandoning two lld ezs inside of the leads.This report is to reflect 1/2 abandoned lld ezs.

Manufacturer Narrative

The other lld abandoned in this case will be reported under mdr report number 1721279-2014-00105.The visisheath involved in this injury will be reported under mdr report number 1721279-2014-00104.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD EZ
• Manufacturer (Section D): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: sondra chandler rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472530
• MDR Report Key: 3887354
• MDR Text Key: 4672915
• Report Number: 1721279-2014-00106
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/01/2014
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP12K01A
• Other Device ID Number: M204518062168011014FLP12K01A6K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: MDT 6949 SPRINT FIDELIS (IMPL. 2004); SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; MDT 5076 CAPSUREFIX NOVUS (IMPL. 2004); SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE EZ
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 70