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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 AT75144
Device Problems Break (1069); Inflation Problem (1310); Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2022).
 
Event Description
It was reported that during angioplasty procedure due to the occlusion and stenosis in the right brachiocephalic vein, the pta balloon allegedly had inflation issue.It was further reported that the tip of the balloon allegedly separated.The procedure was completed using another device.There was no reported patient injury.
 
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.Four electronic photos were provided for review.First and third photo shows a word file displayed in monitor, second photo shows label referring lot number and catalogue number and fourth photo shows a part of catheter, based on the photos reviewed no confirmations can be made.The sample was bloody.Under magnification a circumferential break was noted at the proximal glue joint.Distal tip of the balloon was noted to be present.Therefore, the investigation is confirmed for the identified break issue as break was noted at the glue joint.The investigation is unconfirmed for the reported detachment issue as distal tip of the balloon was present and not detached.The investigation is inconclusive for the inflation issue as functional testing could not be performed due to the condition of the device.A definitive root cause for the reported inflation problem, detachment and break issue could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 01/2022), g3.H11: h6 (device, method, result and 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.H3 other text : see h10.
 
Event Description
It was reported that during angioplasty procedure due to the occlusion and stenosis in the right brachiocephalic vein, the pta balloon allegedly had inflation issue.It was further reported that the tip of the balloon allegedly separated.The procedure was completed using another device.There was no reported patient injury.
 
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Brand Name
ATLAS PTA DILATATION CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key11116440
MDR Text Key225082067
Report Number2020394-2020-21023
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741062438
UDI-Public(01)00801741062438
Combination Product (y/n)N
PMA/PMN Number
K120971
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAT75144
Device Catalogue NumberAT75144
Device Lot NumberGFDN2744
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2021
Date Manufacturer Received05/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
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