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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQ75104
Medical Device Problem Codes Break (1069); Inflation Problem (1310); Material Twisted/Bent (2981)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation is confirmed for inflation issue, break and twisted inner catheter.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cq75104 pta balloon dilatation catheter allegedly experienced inflation problem, break and material twisted.This information was received from one source.The event involved a patient with no known impact to the patient.The (b)(6) year old female patient was (b)(6) lbs.
 
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Brand Name
CONQUEST PTA DILATATION CATHETER
Common Device Name
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10286849
Report Number2020394-2020-04557
Device Sequence Number515451
Product Code DQY
UDI-Device Identifier00801741063220
UDI-Public(01)00801741063220
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberCQ75104
Device Catalogue NumberCQ75104
Device Lot NumberREDV3158
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/16/2020
Patient Sequence Number1
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