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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 Deflation Problem (1149); Retraction Problem (1536)
Patient Problem Death (1802)
Event Date 01/10/2019
Event Type  Death  
Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed. The return of the device is pending. The investigation of the reported event is currently underway. (expiry date: 09/2021).

 
Event Description

It was reported that during an angioplasty procedure in the basilic vein, the pta balloon allegedly could not be deflated. A needle stick was used to puncture the balloon through the skin to deflate. It was further reported that the device was difficult to remove from the patient. The graft was damaged as a result, and replaced. Another device was used to complete the procedure. It was further reported that four days post procedure, the patient expired. The cause of the patient¿s death was not provided. No other pertinent patient, device or medical information was provided leading up to or surrounding the event.

 
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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 Key8317309
MDR Text Key135424527
Report Number2020394-2019-00109
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeTW
PMA/PMN NumberK083657
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 05/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCQ7584
Device Catalogue NumberCQ7584
Device LOT NumberRECX0945
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/06/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/26/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/07/2019 Patient Sequence Number: 1
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