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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD #2
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SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD #2 Back to Search Results
Model Number 518-019
Device Problem Failure to Advance (2524)
Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Injury (2348); Pericardial Effusion (3271)
Event Date 05/13/2014
Event Type  Injury  
Event Description
Lead extraction case to extract four cardiac leads due to cied system infection.The first two leads (1188 ra pacing and 1246 rv pacing, both implanted 216 months) were prepped with an lld #2.Extraction began on the left side and a laser sheath with outer teflon sheath was used, however progress stalled at the area of the clavicle.A cook dilating sheath was then used, followed by a visisheath and a cook evolution, however none of the devices were able to cross.A cook byrd dilator sheath was then used to successfully advance.A combination of cook dilating sheath and laser catheter failed to go beyond the most superior margins of the svc.At that time, because the leads were falling apart, the physician moved to the leads on the right side.These two leads (5076 ra pacing and 5076 rv pacing, both implanted 120 months) were prepped with a cook liberator and an lld-ez and extracted successfully.The physician then decided to extract the left-sided leads using a femoral approach.A cook femoral workstation was prepared and extraction on the left-sided leads was resumed about an hour after the previous attempt.Upon advancing and maneuvering the cook workstation, a drop in blood pressure was noted.An effusion was noted, a pericardiocentesis was performed, and within 10 minutes the physician had access to the heart where an injury was found and repaired in the innominate.The patient survived the intervention.Two llds required situational abandonment secondary to the injury and rescue.
 
Manufacturer Narrative
The second lld that required situational abandonment is captured in report 1721279-2014-00094.The injury that occurred in this case is captured in report 1721279-2014-00091.
 
Manufacturer Narrative
Additional information provided in this report: patient's weight, co-morbidities, and pre-op labs/testing have been added to the report.
 
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Brand Name
SPECTRANETICS LEAD LOCKING DEVICE
Type of Device
LLD #2
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 Key3854647
MDR Text Key4620670
Report Number1721279-2014-00093
Device Sequence Number1
Product Code DRB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model Number518-019
Device Catalogue Number518-019
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/26/2014
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 Number1
Treatment
SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ; 1246 RV PACING CARDIAC LEAD (IMPL 216 MONTHS); COOK BYRD WORKSTATION FEMORAL IV RETRIEVAL SET; COOK EVOLUTION MECHANICAL DILATOR SHEATH; MEDTRONIC CAPSURE 5076 RV PACING (IMPL 120 MON); 1188 RA PACING CARDIAC LEAD (IMPL 216 MONTHS); COOK BYRD DILATOR SHEATH; MEDTRONIC CAPSURE 5076 RA PACING (IMPL 120 MON); COOK LIBERATOR BEACON TIP LOCKING STYLET; SPECTRANETICS LEAD LOCKING DEVICE LLD #2; SPECTRANETICS VISISHEATH DILATOR SET
Patient Outcome(s) Other;
Patient Age82 YR
Patient Weight86
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