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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number ATG80166
Device Problems Retraction Problem; Detachment of Device or device Component; Device Dislodged or Dislocated
Event Date 11/29/2018
Event Type  Injury  
Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The return of the device is pending. The results of the anticipated device evaluation will be provided upon completion of the event investigation.

 
Event Description

It was reported that during a venous recanalization procedure in the iliac vein the pta balloon allegedly detached from the catheter shaft during removal from the patient. The detached material could not be snared and a stent was used to pin the detached material to the vessel wall. There was no reported patient injury.

 
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Brand NameATLAS GOLD 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)
FUTUREMATRIX INTERVENTIONAL
1605 enterprise street
athens TX 75751
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe , AZ 85281
4803032689
MDR Report Key8189338
Report Number2020394-2018-02236
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 03/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberATG80166
Device LOT Number93UC0206
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/22/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/15/2018
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: 12/21/2018 Patient Sequence Number: 1
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