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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ATLAS PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number AT120144
Device Problems Peeled/Delaminated (1454); Retraction Problem (1536); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2018
Event Type  malfunction  
Manufacturer Narrative
No device and no medical records were provided to the manufacturer; however a photo of the sample was provided and is currently being investigated. The lot number for the device was provided. The device history records are currently under review. 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 after a angioplasty procedure in the left iliac vein, the pta balloon fibers were found to be allegedly unraveled and peeling off of the balloon. It was further reported that there was difficulty retracting the balloon through the sheath. There was no reported patient injury.
 
Manufacturer Narrative
The device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. 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 not returned, however one electronic photo was provided for review. Based on the photo review, the investigation is confirmed for peeling of the outer pebax. However, the investigation is inconclusive for the reported unraveled balloon fibers and retraction issue, as the photo review could not confirm the reported issues, and as the sample was not returned for full visual and functional evaluation of the device. The definitive root cause for the identified peeled pebax or reported fiber and retraction issues could not be determined based upon 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. (expiry date-07/2020).
 
Event Description
It was reported that after a angioplasty procedure in the left iliac vein, the pta balloon fibers were found to be allegedly unraveled and peeling off of the balloon. It was further reported that there was difficulty retracting the balloon through the sheath. There was no reported patient injury.
 
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Brand NameATLAS PTA 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 Key7447442
MDR Text Key106271370
Report Number2020394-2018-00420
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K120971
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2020
Device Model NumberAT120144
Device Catalogue NumberAT120144
Device Lot NumberGFBU1447
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 Received06/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2017
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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