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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
Event Date 04/28/2015
Event Type  Injury  
Event Description

This was a left-sided lead extraction to remove one bsc dual coil icd lead (model # 0185, implanted 75 months) due to malfunction. The lead was prepped with an lld #2. A 14f glidelight laser sheath was opened and used for about 35 seconds of lase time. It was then decided to upsize to a 16f glidelight which was used for 145 seconds with successful removal of the icd lead. Within 30 seconds of lead removal, the patient became hypotensive. Tte showed a small pericardial effusion not present prior to the procedure (location of injury was the rv apex). The extractor used a pericardiocentesis kit to remove ~200-250 cc of blood. The patient was stabilized and monitored by the ep physician, staff, rn team, cv surgeon, and anesthesia. The patient was sent to recovery. Six days later, on (b)(6) 2015, the patient expired due to complications with anesthesia. This event is being reported with the lld as the suspect device as it was the traction platform being used to pull the lead free from the myocardium.

 
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Brand NameSPECTRANETICS LEAD LOCKING DEVICE
Type of DeviceLLD #2
Manufacturer (Section D)
SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
Manufacturer (Section G)
SPECTRANETICS CORPORATION
Manufacturer Contact
jessica hearn
9965 federal drive
colorado springs , CO 80921
7194472258
MDR Report Key4760295
Report Number1721279-2015-00077
Device Sequence Number1
Product CodeDRB
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2015
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
Device LOT NumberUNKNOWN
OTHER Device ID NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/28/2015
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 TREATMENT DATA
Date Received: 05/08/2015 Patient Sequence Number: 1
Treatment
BSC 0185 DUAL COIL ICD LEAD (IMPL 75 MON)
SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
SPECTRANETICS 14F GLIDELIGHT LASER SHEATH
SPECTRANETICS 16F GLIDELIGHT LASER SHEATH
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