WAVELINQ 4 FR W04200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-13 for WAVELINQ 4 FR W04200 manufactured by Bard Peripheral Vascular, Inc..

Event Text Entries

[179400312] The lot number for the device was provided. The device history records are currently under review. The device has been returned for evaluation. The investigation is currently underway. (expiry date: 09/2021).
Patient Sequence No: 1, Text Type: N, H10


[179400313] It was reported that during the arteriovenous fistula creation procedure, the electrode of the venous catheter was identified allegedly deformed (misshaped) under fluoroscopy prior to activation; therefore, the venous catheter was not activated and removed from the patient without incident. Reportedly, another venous catheter was used to complete the procedure. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020394-2020-01008
MDR Report Key9708398
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-02-13
Date of Report2020-03-09
Date of Event2020-01-17
Date Mfgr Received2020-03-04
Date Added to Maude2020-02-13
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 ContactJUDITH LUDWIG
Manufacturer Street1415 W. 3RD STREET
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1BARD PERIPHERAL VASCULAR, INC.
Manufacturer Street1625 W 3RD ST.
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal Code85281
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWAVELINQ 4 FR
Generic NameENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE
Product CodePQK
Date Received2020-02-13
Returned To Mfg2020-01-29
Model NumberW04200
Catalog NumberW04200
Lot NumberS0081
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBARD PERIPHERAL VASCULAR, INC.
Manufacturer Address1625 W 3RD ST. TEMPE AZ 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.