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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD EZ LEAD LOCKING DEVICE; STYLET, CATHETER

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SPECTRANETICS CORPORATION LLD EZ LEAD LOCKING DEVICE; STYLET, CATHETER Back to Search Results
Model Number 518-062
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/19/2024
Event Type  Injury  
Event Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead from a right sided approach, due to non function.A spectranetics lld ez lead locking device (lld ez) was inserted into the lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath, advancement was made to 2 inches from the lead tip when the patent's blood pressure dropped.Blood was detected in the right side of the chest via x-ray and transesophageal echocardiography (tee).Rescue efforts began, including rescue balloon, bypass and sternotomy.A superior vena cava (svc) perforation was discovered and repaired (mdr #3007284006-2024-00072).At that time, the decision was made to abandon the rv lead.There was no attempt to unlock the lld from the lead, and the lead and lld ez were cut and capped and remained in the patient mdr #).This report captures the lld ez within the rv lead which was cut and capped and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.
 
Manufacturer Narrative
H3): a portion of the device was discarded, and a portion remained within the patient, thus no investigation could be completed.H6): although lld cut/cap is a known risk of complication with use of the lld, the physician did not attempt to unlock the lld from the lead prior to cutting and capping.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
 
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Brand Name
LLD EZ LEAD LOCKING DEVICE
Type of Device
STYLET, CATHETER
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
barbara creel
9965 federal drive
colorado springs, CO 80921
719447-246
MDR Report Key19089609
MDR Text Key339940856
Report Number3007284006-2024-00073
Device Sequence Number1
Product Code DRB
UDI-Device Identifier20813132023076
UDI-Public(01)20813132023076(17)251120(10)FLP23L16A
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142116
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
Report Date 04/11/2024
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? Yes
Device Operator Health Professional
Device Model Number518-062
Device Catalogue Number518-062
Device Lot NumberFLP23L16A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2023
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
BIOTRONIK SOLIA S53 RV PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
Patient Outcome(s) Other;
Patient Age56 YR
Patient SexFemale
Patient EthnicityHispanic
Patient RaceWhite
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