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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
Model Number AT75166
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2022
Event Type  malfunction  
Event Description
It was reported that during an angioplasty procedure via femoral vein, the balloon allegedly failed to deflate.It was further reported that the balloon was punctured with the back end of the guidewire.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
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.(expiry date: 03/2025).
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one atlas pta dilatation catheter was returned for evaluation.On the visual evaluation, the balloon had a tear near the distal tip and the inner guide lumen was noted to have broken.The distal tip was noted to prolapse.Both the maker bands were present.No other anomalies were noted.As per the reported event the balloon was punctured at the time of the procedure by the user facility, hence the functional testing couldn¿t be performed.Therefore, the investigation for the reported deflation issue remains inconclusive due to the condition of the returned for evaluation caused by the procedure conducted at the user facility.The functional testing couldn¿t be performed.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.H10: d4 (expiry date: 03/2025), g3, h6(method).H11: h6(result, conclusion).H11: section a through f - the information provided by bd 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 bd.
 
Event Description
It was reported that during an angioplasty procedure via femoral vein, the balloon allegedly failed to deflate.It was further reported that the balloon was punctured with the back end of the guidewire.The procedure was completed using another device.There was no reported patient injury.
 
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Brand Name
ATLAS
Type of Device
PTA 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 12804
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key15110377
MDR Text Key297522250
Report Number2020394-2022-00613
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741062476
UDI-Public(01)00801741062476
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120971
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/28/2022
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 NumberAT75166
Device Catalogue NumberAT75166
Device Lot NumberGFGQ2397
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/30/2022
Initial Date FDA Received07/27/2022
Supplement Dates Manufacturer Received07/28/2022
Supplement Dates FDA Received08/02/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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