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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 Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2021
Event Type  malfunction  
Event Description
It was reported that during an ivc filter removal procedure, the intravascular balloon allegedly would not deflate.The balloon was punctured via an access through the internal jugular and was removed off the patient.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.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported deflation issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 03/2024).
 
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.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported deflation issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 03/2024).
 
Event Description
It was reported that during an ivc filter removal procedure, the intravascular balloon allegedly would not deflate.The balloon was punctured via an access through the internal jugular and was removed off the patient.There was no reported patient injury.
 
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Brand Name
ATLAS GOLD
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
FUTUREMATRIX INTERVENTIONAL
1605 enterprise street
athens 75751
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13497589
MDR Text Key285331012
Report Number2020394-2022-00082
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741060816
UDI-Public(01)00801741060816
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Physician
Type of Report Initial
Report Date 01/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberATG80164
Device Catalogue NumberATG80164
Device Lot Number93PF0071
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/13/2022
Initial Date FDA Received02/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Weight73 KG
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