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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 ATG120186
Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/13/2018
Event Type  Injury  
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.
 
Event Description
It was reported that during an angioplasty procedure in the pelvic veins, the pta balloon allegedly had issues retracting and sequentially detached. A stent was used to pin the detached balloon material to the vessel wall. Another device was used to complete the procedure. There was no reported patient injury.
 
Event Description
It was reported that during an angioplasty procedure in the pelvic veins, the pta balloon allegedly had issues retracting and sequentially detached. A stent was used to pin the detached balloon material to the vessel wall. 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 summary: the device was returned for evaluation. A visual inspection found the balloon to be fully detached from the proximal and distal weld locations. Remnants of balloon material were noted at both weld locations, indicating a completed weld had been made. Therefore, the investigation is confirmed for a complete balloon detachment. Additionally, the inner guidewire lumen was found to be stretched. Therefore, based on the detached balloon and stretching of the inn lumen, the investigation is confirmed for the reported retraction issue. The investigation is also confirmed for dislodged marker bands as both bands were found to have dislocated distally on the inner lumen. The marker bands likely dislodged as the balloon detached distally. It is likely that the detachment of the balloon resulted in the retraction issues through the sheath. However, the definitive root cause for the identified balloon detachment 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. 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.
 
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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 Key7967917
MDR Text Key123797549
Report Number2020394-2018-01909
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,foreig
Type of Report Initial,Followup
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberATG120186
Device Lot Number93JZ0039
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/15/2018 Patient Sequence Number: 1
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