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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
Model Number CQ7584
Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Material Rupture (1546); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/28/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records or images/photos have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
 
Event Description
It was reported that a pta balloon was inflated to 25 atm (rbp is 27 atm), the tip of the balloon was allegedly round in shape.Reportedly, the health care professional deflated and removed the balloon.Upon removal, unraveled balloon material was noticed.There was no reported patient injury.
 
Event Description
It was reported that a pta balloon was inflated to 25 atm (rbp is 27 atm), the tip of the balloon was allegedly round in shape.Reportedly, the health care professional deflated and removed the balloon.Upon removal, unraveled balloon material was noticed.There was no reported patient injury.
 
Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Investigation summary: the device was returned for evaluation.A visual inspection found the pebax to be peeled from the balloon throughout the length of the balloon.Additionally, fiber disturbance was noted on the distal cone of the balloon.Therefore, the investigation is confirmed for peeled pebax and for frayed material; no unraveled fibers were noted.The balloon was inflated with water, and the distal cone of the balloon took on an asymmetrical shape, confirming the investigation for the reported round shape of the balloon.The identified fiber disturbance contributed to the reported asymmetric inflation shape.However, the definitive root cause for the identified fiber disturbance or peeled pebax could not be determined based upon the available information.
 
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Brand Name
CONQUEST PTA BALLOON 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 Key7456963
MDR Text Key106409482
Report Number2020394-2018-00477
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741063114
UDI-Public(01)00801741063114
Combination Product (y/n)N
PMA/PMN Number
K083657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/18/2018
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 Expiration Date10/31/2020
Device Model NumberCQ7584
Device Catalogue NumberCQ7584
Device Lot NumberREBY1771
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2018
Initial Date Manufacturer Received 03/28/2018
Initial Date FDA Received04/24/2018
Supplement Dates Manufacturer Received06/29/2018
Supplement Dates FDA Received07/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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