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

Model Number UNAVAILABLE

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

Device model number, lot number, udi number, and expiration date are unavailable.The device was discarded by the user before this information could be obtained.Device manufacture date is dependent on device lot number, thus is unavailable.

Event Description

It was reported that during a lead extraction procedure to remove two non-functional cardiac leads (ra and rv), the rv lead broke.Reportedly, the rv lead had been prepped with a spectranetics lead locking device (lld) and a glidelight laser sheath and tightrail device were used to make progress down the lead.When traction force was applied to the lead, it came apart.The remainder of the lead was reportedly retrieved from the patient using femoral snares.The procedure was completed successfully and both leads were removed.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6559855
• MDR Text Key: 74934413
• Report Number: 1721279-2017-00079
• 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,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: BOSTON SCIENTIFIC ICD LEAD 4243 (IMPL 215MO); BOSTON SCIENTIFIC PACING LEAD 4034 (IMPL 215MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 59