SPECTRANETICS 16F GLIDELIGHT LASER SHEATH 500-303

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-01-10 for SPECTRANETICS 16F GLIDELIGHT LASER SHEATH 500-303 manufactured by The Spectranetics Corporation.

Event Text Entries

[177008132] Patient date of birth unavailable. Patient weight unavailable.
Patient Sequence No: 1, Text Type: N, H10


[177008133] A lead extraction procedure commenced to remove two leads: a right atrial (ra) lead and a right ventricular (rv) lead due to infection. The physician attempted to retract the screws on the distal ends of the rv and ra but were unsuccessful. Spectranetics lead locking devices (ldl's) were placed inside each lead to provide traction. The physician began using a spectranetics 14f glidelight device for lead removal attempt, but encountered stalled progression in the subclavian region. A spectranetics 10f sightrail device was then used with no further progress. The team then attempted to use a snare from a femoral insertion site but was unsuccessful. They then used a metal sheath (cook medical) and were able to get progress using this, along with the glidelight and sightrail devices. They encountered stalled progression in the superior vena cava (svc) region. The physician then upsized to a 16f glidelight device; however the patient's blood pressure dropped. There was no sign of a cardiac effusion but a shadow was noticed in the patient's right chest. The patient was transferred to icu and there it was confirmed that the patient's blood pressure continued to drop. It was decided to commence rescue efforts, including sternotomy. A small hole was discovered at the svc/ra junction. The repair to the hole was successfully completed. Both the ra and rv leads and ldl's within them were cut, capped, and remained in the patient, and it was noted that the physician did not attempt to unlock either lld prior to cutting and capping the leads/ldl's. There is no reported malfunction of any spectranetics devices used in the procedure. The patient survived. This report captures the injury to the svc/ra junction while the glidelight device was in use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721279-2020-00007
MDR Report Key9575624
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-01-10
Date of Report2019-12-16
Date of Event2019-12-13
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2019-12-16
Device Manufacturer Date2019-06-12
Date Added to Maude2020-01-10
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 ContactMRS. BARBARA CREEL
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 16F GLIDELIGHT LASER SHEATH
Generic NameGLIDELIGHT
Product CodeMFA
Date Received2020-01-10
Model Number500-303
Catalog Number500-303
Lot NumberFGC19F12A
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 Received2020-01-10
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2020-01-10

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