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U.S. Department of Health and Human Services

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

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SPECTRANETICS SPECTRANETICS LEAD LOCKING DEVICE; LLD-EZ Back to Search Results
Model Number 518-062
Device Problems Break (1069); Material Perforation (2205); Positioning Problem (3009)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Foreign Body In Patient (2687)
Event Date 01/12/2015
Event Type  malfunction  
Event Description
This was a right-sided lead extraction procedure to remove two cardiac leads due to cied pocket infection.The ra epicardial lead was extracted using an lld-ez and a 14f glidelight.It was noted during the extraction of the ra lead that there was difficulty progressing with the glidelight in the area of the subclavian and svc junction.This difficulty was also noted during the extraction of the rv lead.Higher settings (fluence and rate) were used in this area, however the glidelight was not able to get through.The glidelight was then removed and it was noted that the laser sheath was damaged (red light was visible through the sheath).The physician then used a cook evolution mechanical sheath, however it was not able to progress through the same area.It was noted at this time that the patient began to bleed, however the physician did not believe it to be urgent.Another 14f glidelight was used, however there was difficulty progressing in the same area again.Upon removal of the catheter, damage to the outer insulation was noted again (similar to first glidelight).The patient began to bleed more heavily and a sternotomy was performed.Two holes in the subclavian vein were found and repaired.Due to the complexity of the case and the injury that occurred, the physician elected to cut and cap the ra lead and abandon the lld inside the lead.The plan is to perform another lead extraction via a femoral approach at a later date to extract the abandoned lead and lld.The patient stabilized and was sent to recovery following the procedure.This report is being filed for the lld requiring situational abandonment inside the patient's vasculature.
 
Manufacturer Narrative
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Manufacturer Narrative
New information regarding this event received and updated in this file, including: patient's date of birth and age; patient's medical history / co-morbidities; lead information.
 
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Brand Name
SPECTRANETICS LEAD LOCKING DEVICE
Type of Device
LLD-EZ
Manufacturer (Section D)
SPECTRANETICS
9965 federal drive
colorado springs CO 80921
Manufacturer (Section G)
SPECTRANETICS
Manufacturer Contact
jessica hearn
9965 federal drive
colorado springs, CO 80921
7194472258
MDR Report Key4481588
MDR Text Key5563626
Report Number1721279-2015-00021
Device Sequence Number1
Product Code DRB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K043401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/12/2015
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 Number518-062
Device Catalogue Number518-062
Device Lot NumberUNKNOWN
Other Device ID NumberPARTIAL: M2045180620
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/12/2015
Initial Date FDA Received02/03/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/09/2015
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 Number1
Treatment
RV ICD (INFORMATION UNKNOWN); MEDTRONIC 4076 RA EPICARDIAL LEAD (IMPL 56 MON); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; MEDTRONIC 6935 RV ICD LEAD (IMPL 56 MON); SPECTRANETICS LEAD LOCKING DEVICE; RA EPICARDIAL LEAD (INFORMATION UNKNOWN); 14F GLIDELIGHT LASER SHEATH X2; COOK EVOLUTION MECHANICAL DILATOR SHEATH
Patient Outcome(s) Other;
Patient Age63 YR
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