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

Catalog Number	US3513054
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the results of the clinical trial that approximately seven months and thirteen days post index procedure, the subject underwent target limb re-intervention on the left superficial femoral artery by using scoring balloon and drug coated balloon.It was further reported that during re-intervention, the subject had an adverse event of dissection in the proximal superficial femoral artery on the left leg.Reportedly, the adverse event was not related to study device and study procedure and the lesion was stented.Furthermore, the subject had an another adverse event of circulatory dysregulation of hypotension and bradycardia after percutaneous transluminal angioplasty.The current status of the patient was unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f ¿ the information provided 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.
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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 through the results of the clinical trial that approximately seven months and thirteen days post index procedure, the subject underwent target limb re-intervention on the left superficial femoral artery by using scoring balloon and drug coated balloon.It was further reported that during re-intervention, the subject had an adverse event of dissection in the proximal superficial femoral artery on the left leg.Reportedly, the adverse event was not related to study device and study procedure and the lesion was stented.Furthermore, the subject had an another adverse event of circulatory dysregulation of hypotension and bradycardia after percutaneous transluminal angioplasty.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 through the results of the clinical trial (agility (b)(4) of a non-commercially available device (bd¿ low profile vascular covered stent (lpvcs)), that approximately seven months and thirteen days post index procedure, the subject underwent target limb re-intervention on the left superficial femoral artery left limb using a commercially available lutonix dcb and ultrascore balloon when an adverse event of dissection occurred.The severity of the adverse event was mild.The adverse event was not related to study device.The adverse event was not related to the study procedure.The lesion was stented.The outcome of the adverse event was resolved/recovered.The subject had another adverse event of circulatory dysregulation- hypotension and bradycardia which occurred after the pta procedure.The severity of the adverse event was mild.The adverse event was not related to study device.The adverse event was not related to the study procedure.Ecg was done and the event was resolved already.

• 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: 21571090
• Report Number: 2020394-2025-00312
• Device Sequence Number: 12997023
• Product Code: PNO
• UDI-Device Identifier: 00801741116742
• UDI-Public: (01)00801741116742(17)270728(10)GFJT1538
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: US3513054
• Device Lot Number: GFJT1538
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 06/20/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/19/2025; 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White