FDA.reportPublic FDA data

MAUDE MDR 9881564

MDR report key
9881564
Report number
2024168-2020-02911
Event key
0
Event type
3
Date of event
2020-03-02
Date received
2020-03-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LINDSEY BELL
Address
26531 YNEZ RD. TEMECULA CA 92591 US
Phone
951-951-9519
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HT COMMAND 14GUIDE WIREABBOTT VASCULARDQX20781752078175R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-250

Event Narratives#

N

Patient 1

EVENT ESTIMATED DATE. THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD, CORRECTIVE ACTION TRACKING SYSTEM FOR THE WEB DATABASE REVIEW AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED SINCE THE LOT NUMBER WAS NOT REPORTED. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. BASED ON THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO ADVANCE AND DIFFICULTY TO REMOVE. IN THIS CASE, IT IS POSSIBLE THAT THE LASER DEVICE USED CAUSED DAMAGE TO THE POLYMER COATING CAUSING THE REPORTED DIFFICULTIES HOWEVER; THIS COULD NOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

D

Patient 1

THIS IS BEING REPORTED AS A GENERAL COMMENT INDICATING THAT RESISTANCE DURING ADVANCEMENT AND REMOVAL IS FELT WHEN USING THE HT COMMAND ES GUIDE WIRE WITH AN UNSPECIFIED 014 LASER CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.