SPECTRANETICS LEAD LOCKING DEVICE 518-062

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-18 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.

Event Text Entries

[179921002] Patient's weight unavailable.
Patient Sequence No: 1, Text Type: N, H10


[179921003] A lead extraction procedure commenced to remove two right ventricular (rv) leads and one coronary sinus (cs) lead due to pocket infection and mrsa. Pt had a prior sternotomy (reason believed to be a previous coronary artery bypass graft) and a small pericardial effusion was noted pre-procedure. Spectranetics lead locking devices (lld's) were present in one of the rv leads and in the cs lead to provide traction. Other traction platforms were used as well: cook medical one-tie devices on all three leads, along with the use of a cook medical liberator device and suture on one of the rv leads, all to provide traction. The physician began working to extract one of the rv leads, and with a spectranetics 16f glidelight laser sheath, progress stalled just under the clavicle. A spectranetics 13f tightrail sub-c device progressed to the patient? S midline. The tightrail sub-c device was then used on the cs lead, and progress was made to the patient's midline as well. Then the physician used the 16f glidelight device again on the rv lead, and progress stalled just before the proximal coil in the distal innominate/proximal svc region. The physician then began to work to extract the other rv lead with the 16f glidelight, and this lead was removed successfully. The cs lead was targeted for removal next, and using the 16f glidelight, progress stalled in the innominate region. The physician then used a spectranetics 13f tightrail device to progress to the cs where it advanced no farther; manual traction was then used to remove the cs lead, with just the tip of lead remaining in the patient's cs. Bleeding from the entry site at the pocket was noted, and was significant enough to warrant transfusion. The patient's blood pressure began dropping, with small growth in cardiac effusion noted. Surgical backup was called and rescue efforts began, including use of a rescue balloon, in which blood pressure rose slightly with its use. The surgical team decided the patient was not a candidate for rescue or open chest removal of the remaining rv lead. A spectranetics 13f tightrail was introduced onto this remaining rv lead, with very little progress made. A 13f cook evolution device was introduced, with very little advancement in the vasculature. The patient's blood pressure then dropped substantially. The rescue balloon was utilized again, with no change in blood pressure. Cpr began; a pericardiocentesis was unsuccessful, and ultimately all rescue efforts performed were unsuccessful. The patient did not survive. The autopsy report revealed a 4. 5 cm laceration near the coronary sinus on the posterior rv epicardium, and a lead tip perforation on the rv posterior wall. This report is being submitted to capture the lead tip perforation on the rv posterior wall; it could not be determined which rv lead caused the perforation, and the lld device was used as the traction platform in one of the rv leads.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721279-2020-00037
MDR Report Key9723262
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-18
Date of Report2020-01-21
Date of Event2020-01-21
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-01-21
Date Added to Maude2020-02-18
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 LEAD LOCKING DEVICE
Generic NameLLD
Product CodeDRB
Date Received2020-02-18
Model Number518-062
Catalog Number518-062
Lot NumberFLP19M12A
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 Received2020-02-18
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-02-18

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