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

Model Number 518-062

Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/03/2014

Event Type  Injury  

Event Description

While attempting to remove two leads from patient, physician found them to be bound and would not release from the svc/innominate area, so made a decision to abandon the procedure and cut the leads.Each lead had an lld-ez deployed inside that could not be removed.The leads retracted back into the vein after being cut.There was no harm caused to the patient.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD-EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: linda todd ; 9965 federal drive; colorado springs, CO 80921 ; 7194472567
• MDR Report Key: 3611216
• MDR Text Key: 4069179
• Report Number: 1721279-2014-00019
• 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: 02/03/2014

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: 06/28/2015
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP13F28B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2013
• 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 4012 CARDIAC LEAD; MDT 4016A, CARDIAC LEAD; LLD-EZ
• Patient Outcome(s): Other
• Patient Age: 91 YR
• Patient Weight: 82