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

Model Number	ATG120184
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to an angioplasty procedure, the pta balloon allegedly had labelling issue.There was no patient contact.
Additional Manufacturer Narrative
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.(expiry date: 02/2024).
Event or Problem Description
It was reported that prior to an angioplasty procedure, the pta balloon allegedly had labelling issue.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.An investigation was performed at the manufacturing site into the product labeling.Per the certificate of conformance provided during the manufacturing review, the correct expiration date is 2024-02-24.However, through a labeling review performed at the manufacturing site it was determined that the qr code printed on the 120 length devices were incorrectly tied to a 3 year expiration date, instead of the correct 2 year expiration date.Therefore, the investigation is confirmed for the reported labeling issue, as the qr code printed on the packaging is populated with an incorrect expiration date.A definitive root cause could not be determined based upon the available information.Labeling review: through a labeling review performed at the manufacturing site, it was determined that the qr code printed on the 120 length devices were incorrectly tied to a 3 year expiration date, instead of the correct 2 year expiration date.Per the certificate of conformance, the correct expiration date is 2024-02-24, which matches the expiration date reported printed on the labeling by the user, but the qr code on the labeling incorrectly pulls a 3-year expiration date.H10: d4 (expiry date: 02/2024), g3.H11: h6 (method, 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.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15196728
• Report Number: 2020394-2022-00652
• Device Sequence Number: 6252523
• Product Code: DQY
• UDI-Device Identifier: 00801741060885
• UDI-Public: (01)00801741060885
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/01/2022

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: ATG120184
• Device Catalogue Number: ATG120184
• Device Lot Number: 93PG0147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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