MAUDE Adverse Event Report: SPECTRANETICS CORPORTATION SPECTRANETICS LASER SHEATH II; 14F SLS

Model Number 500-012

Device Problem Physical Resistance (2578)

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

Event Date 05/21/2014

Event Type  Injury  

Event Description

Lead management case to extract two cardiac leads due to cied system infection.The rv lead (sjm 1368 implanted 101 months) was prepped with an lld-ez and extracted with a 14f sls and a 16f sls successfully without complication.The ra lead (sjm unknown model implanted 125 months) was previously abandoned in another procedure; this resulted in the proximal end of the ra lead dropping into the vessel making it impossible to access from a superior approach with the sls.A femoral approach was attempted unsuccessfully so the physician used a gooseneck snare through the sls from the superior approach in the right subclavian.The proximal end of the ra lead was grasped with the snare and inserted into the 14f sls.Some adhesion was met at the right auricle of the ra; the physician lased at this adhesion and the lead released from the cardiac wall.The patient's blood pressure dropped shortly after removal of the lead and an immediate sternotomy was performed.A tear in the right auricle was repaired and the patient survived the intervention.

• Brand Name: SPECTRANETICS LASER SHEATH II
• Type of Device: 14F SLS
• 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: 3846421
• MDR Text Key: 20717942
• Report Number: 1721279-2014-00088
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P960042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/16/2015
• Device Model Number: 500-012
• Device Catalogue Number: 500-012
• Device Lot Number: FJJ13M16B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2013
• 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: SJM 1368 CARDIAC LEAD (IMPL. 101 MO); SJM UNKNOWN MODEL CARDIAC LEAD (IMPL. 125 MO); SPECTRANETICS LEAD LOCKING DEVICE EZ; COVIDIEN GOOSENECK SNARE CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; 16F SPECTRANETICS LASER SHEATH II
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 52 YR