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

Model Number ATG120144

Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)

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

Event Date 04/25/2023

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 return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 02/2026).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.

Event Description

It was reported that during an angioplasty procedure for an abdominal aortic aneurysm graft via femoral access, the pta balloon allegedly ruptured after post dilation of stent.It was further reported that upon removal of the balloon the internal shaft wire separated.The balloon was removed successfully.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one atlas gold pta dilatation catheter was returned for evaluation.The balloon was noted to have broken proximally from the catheter still attached to the distal end; additionally, the entire inner guide wire lumen along with the balloon was also completely detached from the catheter, and the balloon was noted to be prolapsed and covering the marker bands.No objective evidence of balloon rupture or other specific anomalies was noted during the visual evaluation.No functional testing was performed due to the condition of the device.As the returned device for analysis confirmed the balloon had broken from the proximal end and was still attached to the distal end of the catheter, the inner guide wire lumen was noted to be completely detached from the catheter.The balloon was also noted to be prolapsed.Hence, the investigation confirms the reported balloon inner guide wire lumen detachment, the removal difficulty of the detached balloon, and the identified balloon break.However, the investigation remains inconclusive for the reported balloon rupture as no objective evidence could be observed due to the device's condition.A definitive root cause for the reported balloon inner guide wire lumen detachment, the removal difficulty of the detached balloon, and the identified balloon break, reported balloon rupture 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 (expiration date: 02/2026).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.

Event Description

It was reported that during an angioplasty procedure for an abdominal aortic aneurysm graft via femoral access, the pta balloon allegedly ruptured after post dilation of stent.It was further reported that upon removal of the balloon the internal shaft wire separated.The balloon was removed successfully by using snare.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 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: 16974089
• MDR Text Key: 315734821
• Report Number: 2020394-2023-00350
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181323
• Number of Events Reported: 1
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATG120144
• Device Catalogue Number: ATG120144
• Device Lot Number: 93NH0231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2023
• 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
• Patient Age: 58 YR
• Patient Sex: Male