MAUDE Adverse Event Report: SPECTRANETICS CORPORTATION SPECTRANETICS LEAD LOCKING DEVICE; LLD #2

Model Number 518-019

Device Problem Difficult to Remove (1528)

Patient Problems Calcium Deposits/Calcification (1758); Unspecified Infection (1930)

Event Date 09/30/2014

Event Type  Injury  

Event Description

Lead management case to extract two leads due to cied system/pocket infection.The physician prepped both leads with llds but was unable to extract the leads due to severe calcium attaching the leads to the vessel wall.The physician also believed the patient may have a fistula (pre-op status of patient) so to prevent any risk of injury to the patient, the physician decided to cut/cap the llds in the leads.The other cut/capped lld will be reported under 1721279-2014-00167.

Manufacturer Narrative

(b)(4).

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD #2
• 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: 4182546
• MDR Text Key: 19972828
• Report Number: 1721279-2014-00166
• 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: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/05/2016
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC14F05A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2014
• 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 CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE EZ; MDT 5534 CARDIAC LEAD (IMPL. 204 MO); MDT 5034 CARDIAC LEAD (IMPL. 204 MO)
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 49