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

Catalog Number	U357594
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly difficult to insert through the sheath.It was further reported that the guidewire was left and switched the sheath to keep access to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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: one ultraverse 035 dilatation catheter in two segments received for evaluation.During visual evaluation, a complete circumferential break was noted to the catheter shaft.Multiple kinks and stretching were noted to the catheter shaft.Kinks were noted throughout the balloon and to the inner guidewire lumen.Due to the condition of the device, no functional testing was performed.Therefore, the investigation remains inconclusive for the reported sheath insertion difficulty as functional testing could not be performed due to the condition of the device returned.However, the investigation is confirmed for the identified material deformation as kinks were noted to catheter shaft and balloon.Also, the investigation is confirmed for the identified detachment as a complete circumferential break was noted to the catheter shaft.The investigation is confirmed for the identified stretched as stretching was noted to the catheter shaft.A definitive root cause for the alleged sheath insertion difficulty, identified material deformation, detachment and stretching could not be determined based upon the provided information.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 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one ultraverse 035 dilatation catheter in two segments received for evaluation.During visual evaluation, a complete circumferential break was noted to the catheter shaft.Multiple kinks and stretching were noted to the catheter shaft.Kinks were noted throughout the balloon and to the inner guidewire lumen.Due to the condition of the device, no functional testing was performed.Therefore, the investigation is confirmed for the identified detachment and reported sheath removal difficulty as a complete circumferential break was noted to the catheter shaft, which could have caused difficulty in removing the device through the sheath.The investigation is confirmed for the identified material deformation as kinks were noted to catheter shaft and balloon.Also, the investigation is confirmed for the identified stretched as stretching was noted to the catheter shaft.A definitive root cause for the reported sheath removal difficulty, identified material deformation, detachment and stretching could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, d2b, g3, h6 (device, component, result) 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
On (b)(6) 2024, a patient underwent an angioplasty procedure using ultraverse 035 dilatation catheter.During the procedure, the pta balloon was allegedly difficult to remove through the sheath.It was further reported that the guidewire was left and switched the sheath to keep access to complete the procedure.There was no reported patient injury.

• 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: 21371422
• Report Number: 2020394-2025-00168
• Device Sequence Number: 8550677
• Product Code: PNO
• UDI-Device Identifier: 00801741094347
• UDI-Public: (01)00801741094347(11)240215(17)270131(10)CMJP0170
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K142261
• 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): 09/03/2025

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 Catalogue Number: U357594
• Device Lot Number: CMJP0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 84 KG