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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 CQ7588
Device Problem Deflation Problem (1149)
Patient Problem Injury (2348)
Event Date 07/27/2020
Event Type  Injury  
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 sample is pending. The investigation of the reported event is currently underway. (expiry date: 08/2022).

 
Event Description

It was reported that during an angioplasty procedure, the balloon allegedly failed to deflate. It was further reported that a percutaneous needle stick was used to deflate the balloon. The patient status was normal.

 
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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 Key10418752
MDR Text Key203284612
Report Number2020394-2020-05411
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCQ7588
Device Catalogue NumberCQ7588
Device LOT NumberREDW3546
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/18/2020 Patient Sequence Number: 1
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