MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD #2

Model Number 518-019

Device Problem Device Slipped (1584)

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

Event Date 09/25/2015

Event Type  Injury  

Event Description

Lead management case to extract two leads due to cited system/pocket infection.The physician began the procedure by prepping both leads with lld #2 locking stylets.The rv lead was successfully extracted using a 14f sls.The physician then began to extract the ra lead using the 14f sls; however during extraction the lld #2 slipped leading to stretching of the lead.At this time the physician decided to continue the procedure with a femoral approach.An agilis and forceps were then used to apply traction on the lead.The lead broke at that time and tool position was changed using the agilis and forceps.The patient's blood pressure dropped.A pericardiocentesis was performed stabilizing the patient.The remainder of the lead was then removed using an ensnare.Post removal the patient failed to recover and was sent to the operating room where a sternotomy was performed revealing a tear at the right atrial appendage.The patient survived the intervention and was sent to icu for recovery.This adverse event is being reported to reflect on the lld.Lld slippage led to stretching of the lead ultimately requiring the additional intervention.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD #2
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr.; colorado springs CO 80917
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 5167302
• MDR Text Key: 29300767
• Report Number: 1721279-2015-00160
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2015

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 Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR