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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
Catalog Number CQ5062J
Device Problems Material Frayed (1262); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation; therefore, the investigation is inconclusive for the material rupture as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the conquest pta dilatation catheter products that are cleared in the us.The pro code for the conquest pta dilatation catheter products is identified.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model cq5062j pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model cq5062j pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.
 
Manufacturer Narrative
H10: the reported malfunction was reassessed for reportability and determined to be no longer reportable.The catalog number identified in section d4 has not been cleared in the us, but is similar to the conquest pta dilatation catheter products that are cleared in the us.The pro code for the conquest pta dilatation catheter products is identified in d2.H10:g4.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.
 
Manufacturer Narrative
H10: the lot number was provided, therefore a lot history review was not performed.The sample was returned and the investigation is confirmed for the reported longitudinal balloon rupture.The definitive root cause for the reported balloon rupture, identified fiber disturbance, or identified frayed fibers could not be determined based upon available information.The device was labeled for single use.H10: g4.H11: g1, h6 (device code, method, result, conclusion).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.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model cq5062j pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.
 
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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 Key9593571
MDR Text Key178794659
Report Number2020394-2020-00363
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741127175
UDI-Public(01)00801741127175
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup
Report Date 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCQ5062J
Device Lot NumberRECP2128
Date Manufacturer Received06/30/2020
Patient Sequence Number1
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