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,health report with the FDA on 2019-04-25 for WAVELINQ 4 FR W04200 manufactured by Bard Peripheral Vascular, Inc..

Event Text Entries

[143582346] As the lot number for the device was provided, a manufacturing review will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Patient Sequence No: 1, Text Type: N, H10


[143582347] It was reported that during an arteriovenous fistula (avf) creation procedure through the ulnar vein and ulnar artery sites, there was alleged difficulty in the catheters attracting to each other when the catheter were delivered to the target lesion. Reportedly, a successful endoavf was created. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020394-2019-00522
MDR Report Key8553278
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-04-25
Date of Report2019-11-19
Date of Event2019-04-09
Date Mfgr Received2019-11-11
Device Manufacturer Date2019-03-06
Date Added to Maude2019-04-25
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 Street1625 W 3RD ST.
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 Received2019-04-25
Model NumberW04200
Catalog NumberW04200
Lot NumberS0053
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBARD PERIPHERAL VASCULAR, INC.
Manufacturer Address1625 W 3RD ST. TEMPE AZ 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-25

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