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

Catalog Number AT75144

Device Problems Break (1069); Leak/Splash (1354); Peeled/Delaminated (1454)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure in the central vein, the pta balloon allegedly leaked.It was further reported that the part of leakage was between the distal part of balloon and proximal catheter.The procedure was completed using another device.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 pta dilatation catheter was returned for evaluation.Slight peeling and fiber disturbance were noted on the balloon.No other anomalies were noted during the visual examination.On the functional testing, the returned catheter was inflated with an in-house presto inflation device and water was leaking near the proximal balloon joint.Upon further analysis, a partial break was noted at the proximal end of the balloon.No other functional testing was performed.All the anomalies were observed during the microscopic evaluation.One video was reviewed.The video shows the balloon being kept within a bowl of water and being inflated.Upon inflation, a leak was able to be observed in the catheter shaft near the proximal joint of the balloon.The source of the leak is unknown and no other anomalies can be noted in the submitted video.One radiographic video and image was reviewed.Based on the analysis, it was observed that the balloon was at superior vena cava and had been inflated with the contrast solution.It was confirmed that the leak was from the distal aspect of the balloon.No other anomalies noted.Based on the provided radiographic image and photo, it confirmed the leak in the catheter balloon joint and during the return sample analysis the source of the leak was noted to be a partial break in the joint between the catheter and balloon.Further fiber disturbance and slight evidence of peeled peebax was also observed on the balloon during the visual examination.Hence, the investigation is confirmed for the reported leak and identified break in the catheter and balloon joint and fiber disturbance and peel peebax.During the microscopic observation partial break was noted on the proximal end of the catheter and balloon which might contributed to the reported leak, however definitive root cause for the reported leak and identified breaks in the catheter and balloon joint and fiber disturbance and peel peebax 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: 12/2025) 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.See h10.

• Brand Name: ATLAS
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18424607
• MDR Text Key: 331865788
• Report Number: 2020394-2023-01351
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062438
• UDI-Public: (01)00801741062438
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K120971
• 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
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AT75144
• Device Lot Number: GFGY2021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• 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