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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 CQ5072
Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/12/2018
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. (b)(4).
 
Event Description
It was reported that during an angioplasty procedure in the right forearm, the pta balloon allegedly ruptured. Another device was used to complete the procedure. There was no reported patient injury.
 
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Brand NameCONQUEST PTA DILATATION CATHETER
Type of DevicePTA 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.
blvd montebello #1
parque industrial colonial
reynosa tamaulipas 88780
MX 88780
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8181760
MDR Text Key130987272
Report Number2020394-2018-02226
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K083657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberCQ5072
Device Catalogue NumberCQ5072
Device Lot NumberREBY2403
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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