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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 CQ7594J
Device Problems Material Frayed (1262); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2021
Event Type  Malfunction  
Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record 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 catheter products that are cleared in the us. The pro code and 510 k number for the conquest pta dilatation catheter products are identified (expiry date: 03/2023).

 
Event Description

It was reported that during an angioplasty procedure, the pta balloon was allegedly ruptured at 25 atm. It was further reported that 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. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX 88780
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key11537202
MDR Text Key241368490
Report Number2020394-2021-00613
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
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 05/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCQ7594J
Device LOT NumberREER3713
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/05/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated By Manufacturer? Yes
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: 03/22/2021 Patient Sequence Number: 1
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