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

Catalog Number	ATG120186
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, when the doctor started to inflate, the pta balloon allegedly had issues in inflation, and suddenly the pressure was dropped, and then found the blood in the inflation device.It was further reported that, when the doctor moved the catheter, balloon material was apart from the catheter and allegedly fell down into the right atrium.Reportedly, a snare device and a percutaneous transluminal angioplasty balloon were used to remove the balloon material left inside the patient's body when the catheter was removed.The procedure was completed using another balloon.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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.The investigation of the reported event is currently underway.H10: d4 (expiration date: 01/2026).H11: section a through f ¿ the information provided by bd represents all 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 : device pending return.
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 received for evaluation.During visual analysis the balloon completely detached with the catheter and fully inverted condition could be observed.And the fiber material which are torn after detachment were present in the balloon proximal and distal joints.Further the inner guidewire lumen could be observed move forwarded to the distal end with the glue bullet which was not attached to the outer catheter flush hole portion.No other anomalies were observed.Due to the nature of the complaint no further testing was performed.In the visual analysis of return sample balloon fully detached with complete inverted condition could be observed.Further the inner guidewire lumen moved with the glue bullet distally could be observed.Hence the investigation confirmed for the reported balloon detachment and balloon removal difficulty issues.A definitive root cause for the reported balloon detachment and balloon removal difficulty issues could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 01/2026), g3.H11: section a through f ¿ the information provided by bd represents all 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 or Problem Description
It was reported that during an angioplasty procedure, when the doctor started to inflate, the pta balloon allegedly had issues in inflation, and suddenly the pressure was dropped, and then found the blood in the inflation device.It was further reported that, when the doctor moved the catheter, balloon material was apart from the catheter and allegedly fell down into the right atrium.Reportedly, a snare device and a percutaneous transluminal angioplasty balloon were used to remove the balloon material left inside the patient's body when the catheter was removed.The procedure was completed using another balloon.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19227047
• Report Number: 2020394-2024-00580
• Device Sequence Number: 12507503
• Product Code: DQY
• UDI-Device Identifier: 00801741060908
• UDI-Public: (01)00801741060908
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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 Catalogue Number: ATG120186
• Device Lot Number: 93NH0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/22/2024
• 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 Sex: Female