VIDA PTV CATHETER VDA100122

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative,hea report with the FDA on 2015-04-15 for VIDA PTV CATHETER VDA100122 manufactured by Bard Peripheral Vascular, Inc..

Event Text Entries

[5877328] It was reported that prior to patient use, the outer catheter shaft broke. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


[13395008] A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803. The device history records have been reviewed with special attention to the raw materials, the subassemblies, the manufacturing process and the quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for this failure mode. The device was returned. The investigation is confirmed for a break, as a complete circumferential outer shaft break was found at the proximal balloon joint. Based on the visual inspection of the break, it appeared that excessive force may have been applied to the catheter shaft, as the edges of the break were uneven and stretched. However, the definitive root cause for the outer shaft break could not be determined. Potential complications related to a break is adequately addressed in the current ifu (instructions for use). The information provided by bard 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 bard.
Patient Sequence No: 1, Text Type: N, H10


[28478814] To ensure compliance to 21 cfr 803. 50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided. Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and/or procedural details (e. G. Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation. The report source did not have any additional details to provide at this time.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2020394-2015-00235
MDR Report Key4781434
Report Source07,COMPANY REPRESENTATIVE,HEA
Date Received2015-04-15
Date of Report2014-03-17
Date of Event2014-03-17
Date Mfgr Received2015-09-09
Device Manufacturer Date2013-08-01
Date Added to Maude2015-06-17
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 WEST 3RD ST.
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1FUTUREMATRIX INTERVENTIONAL
Manufacturer Street1605 ENTERPRISE STREET
Manufacturer CityATHENS TX 75751
Manufacturer CountryUS
Manufacturer Postal Code75751
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVIDA PTV CATHETER
Product CodeOMZ
Date Received2015-04-15
Returned To Mfg2014-03-25
Catalog NumberVDA100122
Lot Number93HX0100
Device Expiration Date2015-08-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBARD PERIPHERAL VASCULAR, INC.
Manufacturer Address1625 WEST 3RD ST. TEMPE AZ 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
10 2015-04-15

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