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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 CQ7568
Device Problems Inflation Problem (1310); Peeled/Delaminated (1454); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a device history review was performed. The sample was returned to the manufacturer for inspection/evaluation. Investigation of the received sample confirmed the alleged malfunction. Balloon rupture was noted to be the likely root cause for the inflation issue. However, the definitive root cause for the balloon rupture and peeled pebax could not be determined based on available information. It is unknown whether patient or procedural issues contributed to the event. The device is labeled for single use.
 
Event Description
This report summarizes one malfunction. A review of the reported information indicated that model cq7568 pta dilatation catheter allegedly experienced pinhole balloon rupture and had inflation issue. This information was received from one source. Of the one malfunction, one patient was involved with no patient consequence or impact. The patient was reported to be a (b)(6) year old female weighing (b)(6) lbs.
 
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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
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10286847
MDR Text Key199250832
Report Number2020394-2020-04559
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCQ7568
Device Catalogue NumberCQ7568
Device Lot NumberREDU0438
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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