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

Model Number	AT120144
Medical Device Problem Codes	Material Frayed (1262); Inflation Problem (1310); Peeled/Delaminated (1454); Unraveled Material (1664); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had inflation issue.It was further reported that the balloon was allegedly deformed.Reportedly, after the device was removed, a wire was wrapped around the distal aspect of the balloon.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.The investigation of the reported event is currently underway.(expiry date: 12/2024).
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 photo was provided and reviewed.The photo shows the balloon which appeared to be bloody.The distal end of the balloon was noted to be deformed and unraveled fiber was able to be observed.No other anomalies are noted in the provided photo.One atlas pta dilatation catheter was returned for evaluation.Peeled pebax, fiber disturbance ,frayed fibers, and unraveled fibers were noted on the balloon.A constriction to the balloon made of balloon fibers was also noted.There were no other specific anomalies noted during the visual evaluation.No functional testing was performed due to the condition of the sample and the nature of the complaint.All the anomalies are noted on microscopic observation.Therefore, the investigation is confirmed for the reported material deformation issue as a constriction/deformation to the balloon made of balloon fibers were noted.The reported anomalies were also able to be observed from the provided photo.The investigation is also confirmed for the reported unraveled fiber and identified peeled pebax, fiber disturbance, and frayed fibers as these anomalies were able to be observed on the returned balloon, which was also able to be observed from the provided photo.However, the investigation remains inconclusive for the reported inflation issue as no objective evidence could be noted in the photo and no functional testing was performed due to the condition of the device returned for evaluation.A definitive root cause for the reported material deformation, inflation issue ,unraveled fiber and identified peeled pebax, fiber disturbance, and frayed fibers 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: d4 (expiry date: 12/2024), g3, h6(device, method).H11: h6(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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had inflation issue.It was further reported that the balloon was allegedly deformed.Reportedly, after the device was removed, a wire was wrapped around the distal aspect of the balloon.There was no reported patient injury.

• Brand Name: ATLAS
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 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: 15154603
• Report Number: 2020394-2022-00631
• Device Sequence Number: 5320936
• Product Code: DQY
• UDI-Device Identifier: 00801741062636
• UDI-Public: (01)00801741062636
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K120971
• 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): 08/17/2022

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: AT120144
• Device Catalogue Number: AT120144
• Device Lot Number: GFFZ1710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 08/23/2022
• 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: Unknown