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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 ATG80144
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer. 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. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that during an angioplasty procedure the pta balloon allegedly detached from the catheter shaft and became stuck in the patients vein. There was no reported patient injury.
 
Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for this lot number and failure mode. The device was returned for evaluation. A visual inspection found the balloon to be fully detached from both balloon weld locations, and was not returned. The device was examined under microscopic magnification, and balloon material was present at the weld locations. Both marker bands were noted to be dislodged, and swage marks were present on the inner lumen. Therefore, the investigation is confirmed for balloon detachment, and for dislodged marker bands. It is likely that the marker bands became dislodged when the balloon detached. However, the definitive root cause for the identified detachment or dislodgment could not be determined based on the available information. The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate. (b)(4).
 
Event Description
It was reported that during an angioplasty procedure the pta balloon allegedly detached from the catheter shaft and became stuck in the patients vein. 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
MDR Report Key7830624
MDR Text Key118752780
Report Number2020394-2018-01603
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K122984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/24/2021
Device Catalogue NumberATG80144
Device Lot Number93SC0196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
Is This a Reprocessed and Reused Single-Use Device? No

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