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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 CQ5054J
Device Problems Material Frayed (1262); Peeled/Delaminated (1454)
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. This event has been determined to be mdr reportable. Expiry date (b)(6) 2021.
 
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 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 Key7908307
MDR Text Key121722247
Report Number2020394-2018-01793
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
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 11/21/2018
1 Device was Involved in the Event
0 Patients were 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
Device Catalogue NumberCQ5054J
Device Lot NumberRECP0568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2018
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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