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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE LLD

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SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE LLD Back to Search Results
Model Number UNKNOWN
Event Date 11/25/2015
Event Type  Injury  
Manufacturer Narrative

 
Manufacturer Narrative

 
Event Description

Lead management case to extract 2 cardiac leads. The first lead was successfully extracted using an lld and a 9f tightrail sheath. The second lead was then prepped with an lld and the physician began using a 13f tightrail sheath. During use of this device it was noted that the device handle was stuck and the physician retracted the device, noting that the device tip was not rotating. Another 13f tightrail device was then opened and again the cutting mechanism and handle became stuck. At this time the physician continued the procedure using only traction placed on the lld. A perforation of the svc occurred resulting in patient death. This is to reflect on the lld as it was the traction platform in which to extract the lead.

 
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Brand NameSPECTRANETICS LEAD LOCKING DEVICE
Type of DeviceLLD
Manufacturer (Section D)
SPECTRANETICS CORPORATION
9965 federal dr.
colorado springs CO 80921
Manufacturer (Section G)
SPECTRANETICS
Manufacturer Contact
sondra chandler
9965 federal dr
colorado springs , CO 80921
719447-253
MDR Report Key5311166
Report Number1721279-2015-00193
Device Sequence Number1
Product CodeDRB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/26/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Physician
Device MODEL NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2017
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 TREATMENT DATA
Date Received: 12/18/2015 Patient Sequence Number: 1
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