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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

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BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER Back to Search Results
Model Number ATG80144
Device Problems Migration or Expulsion of Device (1395); Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem Injury (2348)
Event Date 06/11/2020
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 device has not been returned to the manufacturer for evaluation, however photo was provided for review. The investigation of the reported event is currently underway. (expiration date: 10/2022).

 
Event Description

It was reported that during an angioplasty procedure through popliteal artery, the pta balloon allegedly detached from the catheter and migrated into the left pulmonary artery while removal. Reportedly the balloon was retrieved via snare on the next day. The patient status was unknown.

 
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Brand NameATLAS GOLD PTA DILATATION CATHETER
Type of DevicePTA 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
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10238157
MDR Text Key197733822
Report Number2020394-2020-04299
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK181323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberATG80144
Device Catalogue NumberATG80144
Device LOT Number93XD0182
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
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: 07/07/2020 Patient Sequence Number: 1
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