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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 CQ7584
Device Problems Material Frayed (1262); Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2018
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 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 of a right upper arm fistula, the pta balloon material allegedly frayed.There was no reported retraction issues.Another balloon was used to complete the procedure and a stent was deployed successfully.There was no reported patient injury.
 
Manufacturer Narrative
The device history records were reviewed.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.The device was returned for evaluation.No visual anomalies were noted along the length of the balloon catheter.The pebax of the balloon was noted to be peeled along the length of the balloon.There was no identified fiber disturbance or unraveled fibers on the returned device.Therefore, based on the returned sample, the investigation is confirmed for peeled material.The investigation is unconfirmed for the alleged frayed balloon material.The definitive root cause for the identified issues could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.The current ifu (instructions for use) states: when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.Use of the conquest pta dilatation catheter: apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy.While maintaining negative pressure and the position of the guidewire, withdraw the deflated dilatation catheter over the wire through the introducer sheath.Use of a gentle counterclockwise motion may be used to help facilitate catheter removal through the introducer sheath.
 
Event Description
It was reported that during an angioplasty procedure of a right upper arm fistula, the pta balloon material allegedly frayed.There was no reported retraction issues.Another balloon was used to complete the procedure and a stent was deployed successfully.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 Key7287172
MDR Text Key100897491
Report Number2020394-2018-00130
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,user f
Type of Report Initial,Followup
Report Date 03/19/2018
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 Date11/30/2020
Device Model NumberCQ7584
Device Catalogue NumberCQ7584
Device Lot NumberREBY2329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2018
Initial Date Manufacturer Received 01/25/2018
Initial Date FDA Received02/21/2018
Supplement Dates Manufacturer Received03/13/2018
Supplement Dates FDA Received03/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age58 YR
Patient Weight64
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