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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 CQ5064J
Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/31/2018
Event Type  malfunction  
Manufacturer Narrative
No hospital/medical records or medical images 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 catalog number identified has not been cleared in the us, but is similar to the conquest pta dilatation balloon products that are cleared in the us.The 510 k number and pro code for the conquest pta dilatation balloon products are identified.Accordingly, this event has been determined to be mdr reportable.Expiry date 01/2021.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 during an angioplasty procedure, the outer layer of the pta balloon was allegedly peeling off upon removal from the patient.Another balloon was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: 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.Investigation summary: the device was returned for evaluation.A visual inspection found the outer layer to be peeled throughout the length of the balloon.Fiber disturbance was also noted on the distal cone of the balloon.Therefore, the investigation is confirmed for peeled outer layer and frayed material.The definitive root cause for the identified peeled outer layer or frayed balloon fibers could not be determined based upon the available information.An investigation is currently open to address the peeling outer layer issue.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.H10: g4, expiry date 01/2021.The catalog number identified in section d4 has not been cleared in the us, but is similar to the conquest pta dilatation balloon products that are cleared in the us.The 510 k number and pro code for the conquest pta dilatation balloon products are identified in d2 and g5.Accordingly, this event has been determined to be mdr reportable.
 
Event Description
It was reported that during an angioplasty procedure, the outer layer of the pta balloon was allegedly peeling off upon removal from the patient.Another balloon was used to complete the procedure.There was no reported patient injury.
 
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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 Key7908318
MDR Text Key121714222
Report Number2020394-2018-01794
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741127182
UDI-Public(01)00801741127182
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 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCQ5064J
Device Lot NumberRECN1562
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2018
Date Manufacturer Received11/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age77 YR
Patient Weight43
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