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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ATLAS PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number AT75142
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/29/2016
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 not 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 the product dimensions on the box and pouch labels allegedly differed from the dimensions indicated on the hub of the pta balloon catheter. The product was used to perform the procedure. There was no reported patient injury.

 
Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event. The lot met all release criteria. Visual/microscopic inspection: as the sample was not returned for evaluation, a visual/microscopic inspection could not be performed. Functional/performance evaluation: as the sample was not returned for evaluation, a functional/performance evaluation could not be performed. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: the device was not returned. A sales review, complete dhr review and inventory assessment was completed. The investigation is inconclusive for device mislabeling, as the device was not returned for evaluation and additional investigation activities could not confirm the reported event. Per the investigation summary, a 500% visual inspection is completed to verify hub markings. Therefore, it is unlikely this event is manufacturing related. Per the sales review, it is possible a mix up at the facility with atlas pta catheters occurred, as the complaint product catalog number and alleged product catalog number were received by the user facility in the past 12 months. However, based on available information, the definitive root cause could not be determined. Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. Dilatation catheter preparation: remove catheter from package. Verify the balloon size is suitable for the procedure and the selected accessories accommodate the catheter as labeled. 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 the product dimensions on the box and pouch labels allegedly differed from the dimensions indicated on the hub of the pta balloon catheter. The product was used to perform the procedure. There was no reported patient injury.

 
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Brand NameATLAS PTA BALLOON 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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key6267570
MDR Text Key65459574
Report Number2020394-2016-01292
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK052236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/20/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device Catalogue NumberAT75142
Device LOT NumberGFZL2625
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/30/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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