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

Catalog Number	AT120162
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
Additional 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.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 or Problem Description
It was reported that prior to an angioplasty procedure, the measures labeled on the box allegedly did not correspond to the measures of the product inside the box.There was no patient contact.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the measures labeled on the box allegedly did not correspond to the measures of the product inside the box.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: although no samples were returned, two electronic photos were provided for review.Photo one shows an outer packaging carton labeled for a 16x40 mm, but an inner packaging sleeve labeled for a 14x20 mm.Photo two shows an outer packaging carton labeled for a 16x20 mm, but an inner packaging sleeve labeled for a 16x40 mm.Therefore, the investigation is confirmed for the reported product labeling issue as the product inner packaging sleeves were seen to be incorrectly in the outer packaging in the photos.A lot sales review for the reported products and region was reviewed, and all 3 involved lots were seen being sold in the region.Therefore, the investigation is confirmed for the reported product labeling issue as the product inner packaging sleeves were seen to be incorrectly in the outer packaging in the photos.The definitive root cause of the issue was unable to be determined based upon the review of the lot sales information.Labeling review: a lot sales review for the products and region was reviewed, and all 3 lots were seen being sent to distribution center and then to a drop shipment facility in the region.Specific sales info beyond that could not be determined.No product repackaging or over labeling was reported to be done by the distribution center in the region.It is unknown how the products were incorrectly placed in wrong packaging.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.

• 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: 21021281
• Report Number: 2020394-2024-01900
• Device Sequence Number: 14483332
• Product Code: DQY
• UDI-Device Identifier: 00801741062650
• UDI-Public: (01)00801741062650(11)230620(17)260528(11)GFHS1644
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 05/07/2025

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 Expiration Date: 05/28/2026
• Device Catalogue Number: AT120162
• Device Lot Number: GFHS1644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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