SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER 590-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-24 for SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER 590-001 manufactured by The Spectranetics Corporation.

Event Text Entries

[186722481] Patient date of birth unavailable. Patient weight unavailable. Device lot number, expiration date unavailable. Device manufacture date unavailable because device lot number unavailable.
Patient Sequence No: 1, Text Type: N, H10


[186722482] Per the report received from the physician, a lead extraction procedure commenced to remove two right ventricular (rv) leads due to redundancy and need for an upgrade. Prior to the procedure, a spectranetics bridge occluding balloon was prophylactically ''staged'' within the patient's inferior vena cava (ivc). In the event that an emergency occurred during the procedure, the bridge balloon could then be positioned and inflated within the superior vena cava (svc) to provide occlusion of the svc as a rescue measure. One lead was reported to be successfully extracted; however, the ''old'' rv lead was clearly adhered to the septal leaflet of the tricuspid valve, so extraction of this lead was deferred. A thrombus was present on the rv lead which the physician noted as unusual. Use of the bridge balloon was not necessary during the lead extraction procedure. When the bridge balloon was removed from the body after the procedure, the physician noted a thrombus on the bridge balloon. There was no reported patient harm. The manufacturer became aware of this event from a physician presentation and from subsequent conversations with the physician and manufacturer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721279-2020-00063
MDR Report Key9875161
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-24
Date of Report2020-02-27
Date of Event2019-07-01
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-24
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 BRIDGE OCCLUDING BALLOON CATHETER
Generic NameBRIDGE
Product CodeMJN
Date Received2020-03-24
Model Number590-001
Catalog Number590-001
Lot NumberUNAVAILABLE
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 Received2020-03-24
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-24

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