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

Model Number	ATG80126
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Frayed (1262); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, images and video were provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the device allegedly had a leakage.It was further reported that the device deflated and removed.There was no reported patient injury.
Event or Problem Description
It was reported that during an arteriovenous fistula angioplasty procedure, the device allegedly appeared to be leaking under fluoroscopy.It was further reported that the device was deflated and removed immediately.There was no reported patient injury.
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 radio graphic image was reviewed.Images show wire access across the right chest with an angioplasty balloon in place.The balloon is not completely inflated in any of the three images provided.There does not appear to be any definitive signs of contrast leakage outside of the balloon in the images provided.Therefore, based on the image review, the reported leak not be confirmed on the findings no conclusion can be made as the balloon is not completely inflated and no evidence of leak noted from the submitted image.One radio graphic video was reviewed.A video shows a venogram centered on the right chest.A catheter appears to traverse from the right cephalic vein into the central venous system.Due to poor video quality, it is not possible to comment on the specifics of this catheter.An angioplasty balloon is not visualized in this video.It is possible that the catheter/wire visualized is that of an angioplasty platform.Therefore, based on the video review, the reported failure leak could not be confirmed on the findings no conclusion can be made.One atlas gold pta dilatation catheter was returned for evaluation.No specific anomalies noted during the visual evaluation.During the functional evaluation the device was inflated with in-house presto device and the water was leaking from the proximal end of the balloon.Under the microscopic observation material frayed and pinhole rupture was noted.No further testing performed.Therefore, the investigation for the reported leak was confirmed as the device leaks from the proximal end of the balloon during functional evaluation.The investigation was also confirmed for identified balloon rupture as the device leaked during the functional evaluation from the pin-hole rupture.The investigation was also confirmed for identified material frayed as the fiber disturbance noted under microscopic observation.However during microscopic observation pinhole balloon rupture was noted which may contributed to the reported leak.However the definitive root cause for the reported leak, identified balloon rupture and material frayed 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: 09/2023), g3, h6 (method).H11: e1, h6 (device, result, conclusion).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.

• 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: 12874564
• Report Number: 2020394-2021-01996
• Device Sequence Number: 14647581
• Product Code: DQY
• UDI-Device Identifier: 00801741060717
• UDI-Public: (01)00801741060717
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 12/24/2021

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: ATG80126
• Device Catalogue Number: ATG80126
• Device Lot Number: 93VE0134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 11/25/2021
• Supplement Report FDA Received Date: 12/31/2021
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 79 KG