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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ATLAS PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number AT75164
Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)
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 device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. Expiry date (05/2023).

 
Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly had a deflation issue. It was further reported that another incision and sutures were done remove the balloon. Additionally, the doctor had to detach the balloon in order to retrieve the balloon. There was no reported patient injury.

 
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Brand NameATLAS 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)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10418780
MDR Text Key203284916
Report Number2020394-2020-05401
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120971
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 10/05/2020
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 NumberAT75164
Device Catalogue NumberAT75164
Device LOT NumberGFES2235
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/05/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2020
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: 08/18/2020 Patient Sequence Number: 1
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