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

Model Number 518-062

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/19/2014

Event Type  malfunction  

Event Description

Lead management case to extract one biotronik 351337 rv lead (implanted 63 months) due to lead fracture.The lead was prepped by cutting the terminal pin and inserting an lld ez with a cook bulldog for the cables.The physician started the extraction with a 14f glidelight and teflon outer sheath.Lasing was successful until reaching the area just below that clavicle.Several lasing trains were performed with no progress.The physician then decided to upsize to a 16f glidelight but was unable to make any additional significant progress.At this point, the lead broke at the proximal end of the proximal coil.The lld remained in place but obtaining a good rail for full removal was not possible.The physician decided to cut and cap the lld leaving it in the patient.

Manufacturer Narrative

(b)(4).

• 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: 4372426
• MDR Text Key: 5261545
• Report Number: 1721279-2014-00220
• 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: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/18/2016
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP14J18A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• 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: BIOTRONIK 350974 CARDIAC LEAD (IMPL. 63MO); BIOTRONIK 375012 CARDIAC LEAD (IMPL. 1MO); SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; BIOTRONIK 351337 CARDIAC LEAD (IMPL. 63MO); BIOTRONIK 354805 CARDIAC LEAD (IMPL. 63MO)
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 116