SPECTRANETICS 14F GLIDELIGHT LASER SHEATH 500-302

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-26 for SPECTRANETICS 14F GLIDELIGHT LASER SHEATH 500-302 manufactured by The Spectranetics Corporation.

Event Text Entries

[181086673] A lead extraction procedure commenced to remove a right ventricle (rv) lead due to bacteremia, pocket/device erosion, and the patient was positive for a staph infection. Prior to the procedure, the patient's not for resuscitation (nfr) was discussed and the decision was made with the patients? Medical power of attorney and the patient that no surgical rescue was to be performed in the event of major bleeding. As such, against the centers standard procedure, surgical back up and bypass was not available in the room. Lead extraction was performed. A temporary pacing wire was paced through a 6fr right femoral sheath into the rv. Initial difficulty was experienced while placing the temporary wire, however, reliable capture was obtained and pacing was controlled through the temporary wire. The 5076 rv lead helix was retracted and the lead was unable to be removed through simple traction. A spectranetics lead locking device was placed in the lead and lead remained stuck. A spectranetics 14fr glidelight laser sheath was then used. The initial advancement into the innominate vein and under the clavicle was challenging. The outer sheath was then utilized. The glidelight appeared to progress over the lead from the innominate/superior vena cava (svc) interface down to the tricuspid valve with minimal lasing and force. The extraction at this point appeared unremarkable. As the glidelight advanced around tricuspid valve (approximately 2-3 cm from the tip of the rv lead) the anesthesiologist reported a 1 cm pericardial effusion around the apex of the heart. The patients? Blood pressure dropped over the next few minutes. The lead was extracted while the other operator inserted a pericardial drain and approximately 900ml of blood was removed. The glidelight and the drain were kept in place and fluid was added. The patient's blood pressure was stabilized and improved slightly for a few minutes. The blood pressure then dropped again and the pericardial drain was unable to remove any further blood. The echo suggested no rv filling and the effusion was 1. 5 cm. At this point, the decision was made to stop treating the patient as per the previously established medical directive (nfr). The patient expired. Upon further discussion with the philip's representative, the physicians were unclear whether the injury may have been caused by the temporary pacing wire or extraction sheath. The location of the injury was suspected to be somewhere within the pericardium, due to the observed pericardial effusion. There was no reported malfunction of any spectranetics products used during the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721279-2020-00042
MDR Report Key9758411
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-26
Date of Report2020-02-11
Date of Event2020-02-11
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-11
Date Added to Maude2020-02-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. NICOLE WORFORD
Manufacturer Street9965 FEDERAL DRIVE
Manufacturer CityCOLORADO SPRINGS CO 80921
Manufacturer CountryUS
Manufacturer Postal80921
Manufacturer Phone719447-246
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameSPECTRANETICS 14F GLIDELIGHT LASER SHEATH
Generic NameGLIDELIGHT
Product CodeMFA
Date Received2020-02-26
Model Number500-302
Catalog Number500-302
Lot NumberFGB19K24A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerTHE SPECTRANETICS CORPORATION
Manufacturer Address9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921

Device Sequence Number: 101

Product Code---
Date Received2020-02-26
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-02-26

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