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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 CQ75124
Device Problems Material Frayed (1262); Inflation Problem (1310); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was performed.The sample was returned to the manufacturer for evaluation.Therefore, the investigation of the reported event is confirmed for the frayed material, identified longitudinal balloon rupture and unconfirmed for the reported inflation issue.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model cq75124 pta balloon dilatation catheter allegedly experienced inflation issue, frayed and longitudinal rupture.This information was received from one source.The malfunction had patient involvement but the patient had no consequences.The patient was a (b)(6) year old female weighing (b)(6) lbs.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model cq75124 pta balloon dilatation catheter allegedly experienced inflation issue, frayed and longitudinal rupture.This information was received from one source.The malfunction had patient involvement but the patient had no consequences.The patient was a 62 year old female weighing 185 lbs.
 
Manufacturer Narrative
H10: as the lot number for the device was provided, a manufacturing review was performed.The sample was returned to the manufacturer for evaluation.Therefore, the investigation of the reported event is confirmed for the frayed material, identified longitudinal balloon rupture and unconfirmed for the reported inflation issue.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11:section a through f - 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.
 
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Brand Name
CONQUEST PTA DILATATION CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10279442
MDR Text Key199064542
Report Number2020394-2020-04465
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741063251
UDI-Public(01)00801741063251
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCQ75124
Device Catalogue NumberCQ75124
Device Lot NumberREDW0248
Date Manufacturer Received06/30/2020
Patient Sequence Number1
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