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

Model Number 518-062

Device Problem Insufficient Information (3190)

Patient Problem Dry Eye(s) (1814)

Event Date 03/27/2015

Event Type  Injury  

Event Description

Lead management case to extract two non-functional leads.The physician prepped both leads with an lld ez and opened a 14f glidelight laser sheath.The physician was able to make advancement with the glidelight on the rv lead but encountered lead on lead binding.The physician then switched to the ra lead and noted a drop in blood pressure prior to lasing on the ra lead.Fluids were administered and the patient¿s blood pressure returned to pre-extraction range.Lasing began on the ra lead but again was unable to progress and the patient¿s blood pressure dropped once again.The physician stopped the extraction and the blood pressure returned to normal.At this point the physician decided to abandon the two leads rather than risk injury to the patient.The lld ezs were not able to be removed from the lead and were subsequently cut and capped inside.New leads were implanted and the patient was discharged to recovery.The other lld will be reported under emdr # 1721279-2015-00057.

Manufacturer Narrative

(b)(4).Placeholder.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 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: 4671896
• MDR Text Key: 5609965
• Report Number: 1721279-2015-00058
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/12/2017
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP15A12A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2015
• 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 LEAD LOCKING DEVICE EZ; MDT 4024 RV CARDIAC LEAD (IMPL. 246MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; MDT 4524 RA CARDIAC LEAD (IMPL. 246MO)
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 93