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

Model Number	ATG120144
Medical Device Problem Codes	Deflation Problem (1149); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure via left popliteal vein, the pta balloon was allegedly unable to aspirate.Despite repeated aspirations, the pta balloon was unable to deflate.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, video was provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2023).
Additional 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 gold pta dilatation catheter with unknown inflation device was returned for evaluation, inflation catheter was cut, and segment was returned attached to inflation luer of the hub was returned for evaluation.No specific anomalies noted during the visual evaluation.During the functional testing, the balloon was inflated to 6 atm by inhouse presto inflation device.The balloon inflated and maintained pressure.Balloon took two minute and twenty seconds to deflate.The balloon was cut and under the microscopic observation it was noted that both port holes were deformed.No further functional testing was performed.The deflation time is not within the acceptable range as per the product specification limit.One video was reviewed.The video shows a fluoroscopic image of a partially inflated angioplasty balloon with a stent.The exact location of this is likely within the right iliac vasculature.Therefore, based on the video review, the reported deflation issue could not be confirmed on the findings no conclusion can be made.One video was reviewed.The balloon was noted to be in inflated condition connected with an unknown inflation device, the plunger within the device was noted to been in the initial position.No evidence of deflating the balloon could not be noted.Therefore, based on the video review, the reported deflation issue could not be confirmed on the findings no conclusion can be made.He investigation for the deflation issue was confirmed as the balloon time took two minute and twenty seconds to deflate under laboratory conditions and also the deflation was not within the acceptable range of product specification limit.During the microscopic observation it was noted that both port holes were deformed which may lead to the reported deflation issue.However, 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: b5, d4(expiry date: 03/2023).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 or Problem Description
It was reported that during an angioplasty procedure via left popliteal vein, the pta balloon was allegedly unable to aspirate residual amount of contrast agent and it was further reported that the pta balloon was allegedly slow to deflate.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ATLAS GOLD
• Common Device Name: 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 Key: 13152947
• Report Number: 2020394-2021-02145
• Device Sequence Number: 5348033
• Product Code: DQY
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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
• Operator of Device: Health Professional
• Device Model Number: ATG120144
• Device Catalogue Number: ATG120144
• Device Lot Number: 93PE0118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 62 KG