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

Catalog Number ATG120144

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 11/2025).H11: section a through f: the information provide 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 Description

It was reported that during angioplasty procedure in the central vein, the pta balloon allegedly failed to deflate.It was further reported that after the dilation, the balloon allegedly detached from the catheter.It was also reported that the pta balloon catheter was removed using snare and withdrawn the punctured balloon into the sheath and completed the procedure.There was no reported patient injury.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: the physical device was not returned for evaluation.Two photos were reviewed.The first photo shows a completely detached and inverted balloon.The balloon was bloody.The second photo shows the detached balloon and catheter.No other anomalies are noted in the submitted photos.No objective evidence of a puncture site nor tear on the balloon was noted as reported in the user's condition and due to the device's condition.Based on the submitted photos, the balloon shows the evidence of complete detachment from the catheter and the balloon was also noted to be fully inverted within itself.However, the photos show no objective signs of puncture on the balloon material as reported by the user.Hence, the investigation into the reported balloon detachment and difficulty into removing the balloon is confirmed and the investigation remains inconclusive for the reported deflation issue.A definitive root cause for the reported balloon detachment, deflation issue and difficulty into removing the balloon 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: 11/2025), g3, h6 (method).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 Description

It was reported that during angioplasty procedure in the central vein, the pta balloon allegedly failed to deflate.It was further reported that after the dilation, the balloon allegedly detached from the catheter.It was also reported that the pta balloon catheter was removed using snare and withdrawn the punctured balloon into the sheath and completed the procedure.There was no reported patient injury.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17620612
• MDR Text Key: 321935913
• Report Number: 2020394-2023-00620
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K181323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ATG120144
• Device Lot Number: 93YG0162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1