MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035; PTA BALLOON DILATATION CATHETER

Catalog Number	U3513052
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
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 return of the sample is pending.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
On august 21, 2024, it was reported that prior to an angioplasty procedure, the product allegedly had a discrepancy in invoice.It was further reported that seven units of ultraverse 035 pta catheter product was received of which, six units from batch cmjq0320 and one unit from batch cmht0320, but the invoice only shows seven units from batch cmjq0320.Reportedly, the anvisa label of the product with batch cmht0320 shows batch cmjq0320.There was no patient contact.
Additional Manufacturer Narrative
H11: 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.D4 (medical device lot #, medical device expiration date, unique identifier (udi) #), g3.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
On (b)(6) 2024, a patient underwent for a angioplasty procedure using ultraverse 035.Prior to an angioplasty procedure, the product allegedly had a discrepancy in invoice.It was further reported that seven units of ultraverse 035 pta catheter product was received of which, six units from batch cmjq0320 and one unit from batch cmht0320, but the invoice only shows seven units from batch cmjq0320.Reportedly, the anvisa label of the product with batch cmht0320 shows batch cmjq0320.There was no patient contact.
Additional Manufacturer Narrative
H11: 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: although the physical sample was not returned for evaluation, one photo was provided for review.The provided photo shows the actual product labeling applied at the manufacturing facility containing all correct product information for the given product lot number.The provided photo also shows the nationalization labeling that is applied at the bd brazil distribution center prior to release in brazil.This label contains a different lot number and product code than the correct product labeling.Therefore, the investigation is confirmed for the reported labeling problem as the national label applied by the bd brazil distribution center contained incorrect product information.No issues were noted to the labeling applied at the manufacturing facility.The root cause was determined to be a failure in the nationalization labeling process at the bd brazil distribution center, and no failure was identified with the device labeling applied at the manufacturing location.Labeling review: the ultraverse 035 label document (baw1393000 rev.2) was reviewed.The provided photo shows the actual product labeling applied at the manufacturing facility contains all correct product information per this document for lot cmht0320 and product code u3513052.The provided photo also shows the nationalization labeling that is applied at the bd brazil distribution center prior to release in brazil.This label contains a different lot number cmjq0320 than the correct product labeling, and additionally the incorrect product code of u35130515.This nationalization label is added to provide product information in the national language.The product information included on this label was incorrect and does not match the actual provided product information on the manufacturing product label.D4 (medical device catalog #, unique identifier (udi) #), g3, h6 (method, result, conclusion).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
On (b)(6) 2024, a patient underwent an angioplasty procedure using ultraverse 035.Prior to the procedure, the product allegedly had a discrepancy in invoice.It was further reported that seven units of ultraverse 035 pta catheter product was received of which, six units from batch cmjq0320 and one unit from batch cmht0320, but the invoice only shows seven units from batch cmjq0320.Reportedly, the anvisa label of the product with batch cmht0320 shows batch cmjq0320.There was no patient contact.

• Brand Name: ULTRAVERSE 035
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21897290
• Report Number: 2020394-2025-00612
• Device Sequence Number: 11650965
• Product Code: LIT
• UDI-Device Identifier: 00801741092664
• UDI-Public: (01)00801741092664(11)230622(17)260531(10)CMHT0320
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2025

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: 05/31/2026
• Device Catalogue Number: U3513052
• Device Lot Number: CMHT0320
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 11/06/2025; 12/02/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 11/13/2025; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2023
• 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