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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST; PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. CONQUEST; PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number CQ7554J
Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2024
Event Type  malfunction  
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the conquest products that are cleared in the us.The pro code and 510k number for the conquest products is identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 06/2026).H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device pending return.
 
Event Description
It was reported that during an angioplasty procedure, after complete expansion, when the pta balloon was tried to be removed, the balloon allegedly didn't move at all.It was further reported that further a stronger force was tried to remove the balloon however, there had a possibility that the guidewire would break.Reportedly the balloon was removed with the guidewire.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the conquest products that are cleared in the us.The pro code and 510k number for the conquest products is identified in d2 and g4.H10: d4 (expiration date: 06/2026), g3, h6 (device).H11: section a through f ¿ the information provided by bd represents all 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
It was reported that during an angioplasty procedure, after complete expansion, when the pta balloon was tried to be removed, the balloon allegedly didn't move at all.It was further reported that a stronger force was tried to remove the balloon, however, there had a possibility that the guidewire would break.Reportedly, the balloon was removed with the guidewire.The procedure was completed using another device.There was no reported patient injury.
 
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Brand Name
CONQUEST
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX   88780
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key18746181
MDR Text Key335848840
Report Number2020394-2024-00239
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741127373
UDI-Public(01)00801741127373
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K083657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/25/2024
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
Device Operator Health Professional
Device Catalogue NumberCQ7554J
Device Lot NumberREHU2509
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2024
Initial Date FDA Received02/21/2024
Supplement Dates Manufacturer Received04/17/2024
Supplement Dates FDA Received04/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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