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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 Date 06/20/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The return of the device is pending. The results of the anticipated device evaluation will be provided upon completion of the event investigation. 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 during deflation. Reportedly, the detached balloon material was successfully removed from the patient; however a small balloon segment was allegedly stuck behind a stent. 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 in two segments. A visual inspection found a complete balloon detachment from both balloon welds. Evidence of material transfer was noted at both balloon welds. Additionally, the inner guidewire lumen was noted to be detached and pull out from the outer catheter shaft. Both marker bands were noted to be dislodged distally on the guidewire lumen. Therefore, the investigation is confirmed for both balloon and catheter detachment. The investigation is also confirmed for dislodged marker bands. Per the reported event details, the inflated balloon was used near a newly fitted stent. It is possible that an interaction between the stent and balloon contributed to the identified issues. It is likely that the balloon detachment contributed to the dislodged marker bands. However, the definitive root cause for the detachment issues could not be determined based upon 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.
 
Event Description
It was reported that during an angioplasty procedure the pta balloon allegedly detached during deflation. Reportedly, the detached balloon material was successfully removed from the patient; however a small balloon segment was allegedly stuck behind a stent. 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 Key7692656
MDR Text Key114144170
Report Number2020394-2018-01216
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K181323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 10/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/03/2021
Device Catalogue NumberATG80144
Device Lot Number93RC0221
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2018
Is This a Reprocessed and Reused Single-Use Device? No

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