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

Model Number 518-062

Device Problem Physical Resistance (2578)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946)

Event Date 12/15/2014

Event Type  Injury  

Event Description

This was a left-sided lead extraction procedure to remove one class ii functional / advisory rv icd lead (sjm 7000, implanted 89 months).The lead was prepped with an lld and a 14f glidelight with visisheath was initially used, however resistance was met at the proximal coil so the physician upsized to a 16f glidelight (without outer sheath).Progression was smooth until close to the svc/ra junction where resistance was encountered.The physician pulled back the laser sheath to add an outer sheath, however the patient's blood pressure dropped to 50s systolic after the catheter was withdrawn.A sternotomy was performed and a 1 cm tear just above the svc/ra junction was discovered where the lead was calcified and "a part of the svc wall." the injury was repaired and it was decided to cut and cap the lead as removal of the lead would require reconstruction of the svc.This report is for the lld requiring situational abandonment.

• 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: jessica hearn bsn, rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4376386
• MDR Text Key: 20453384
• Report Number: 1721279-2014-00223
• 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: 12/15/2014

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 Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• Other Device ID Number: PARTIAL UDI: M20451806205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 12/31/2014
• 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: SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SJM 7000-65CM RIATA RV ICD LEAD (IMPL 89 MON); SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 110