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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQF7564
Device Problems Peeled/Delaminated (1454); Material Rupture (1546); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2018
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 in the superficial femoral artery, the pta balloon allegedly ruptured after being removed from the patient. Another pta balloon was used to complete the device. 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. This is the only complaint reported to date for this lot number and failure mode. The device was returned for evaluation. A visual inspection found the outer pebax layer to be peeled from the balloon throughout the balloons length. Additionally, the circumferential fibers were noted to be unraveled from the balloon. The device was inflated and water was seen exiting the balloon from a pinhole rupture. Therefore, the investigation is confirmed for both peeled pebax and unraveled fibers, as well as for a pinhole rupture. Per the reported event details, the vessel being treated was 'massively calcified. ' therefore, it is possible that patient factors contributed to the identified fiber and pebax issues. However, the definitive root cause for the identified issues could not be determined based upon available information. The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate. (b)(4).
 
Event Description
It was reported that during an angioplasty procedure in the superficial femoral artery, the pta balloon allegedly ruptured after being removed from the patient. Another pta balloon was used to complete the device. There was no reported patient injury.
 
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Brand NameCONQUEST 40 PTA DILATATION CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7754860
MDR Text Key116233850
Report Number2020394-2018-01380
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K120660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model NumberCQF7564
Device Catalogue NumberCQF7564
Device Lot NumberRECR0696
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

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