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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number ATG80164
Device Problems Leak/Splash (1354); Peeled/Delaminated (1454); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2018
Event Type  malfunction  
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.
 
Event Description
It was reported that during an angioplasty procedure in the external iliac vein, the pta balloon allegedly leaked.Another device was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: 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.Investigation results: the device was returned for evaluation.A visual inspection found peeled pebax on the distal cone of the balloon.The device was inflated, and a rupture was noted on the distal cone of the balloon, at the location of the peeling pebax.Therefore, the investigation is confirmed for a rupture and for peeling pebax.It is likely the user perceived the rupture as a leak.Because the peeling pebax was noted at the location of the rupture, it is unknown if the rupture caused or contributed to the peeling pebax.The definitive root cause for the identified issues could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
 
Event Description
It was reported that during an angioplasty procedure in the external iliac vein, the pta balloon allegedly leaked.Another device was used to complete the procedure.There was no reported patient injury.
 
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Brand Name
ATLAS GOLD PTA BALLOON DILATATION CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key8333316
MDR Text Key136146302
Report Number2020394-2019-00117
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741060816
UDI-Public(01)00801741060816
Combination Product (y/n)N
PMA/PMN Number
K181323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/10/2021
Device Model NumberATG80164
Device Catalogue NumberATG80164
Device Lot Number93UC0080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Date Manufacturer Received05/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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