MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRASCORE 014; FOCUSED FORCE PTA BALLOON

Catalog Number	US14150630
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one ultrascore 014 pta dilatation catheter returned for evaluation.An unknown 014 guidewire was returned in its packaging hoop.During visual evaluation, no kinks noted to the catheter shaft.No anomalies to the luers and y-body.The catheter was loaded onto an unknown sheath.It was noted the distal tip of the balloon was bunched, core wires were bent and there was a kink to the inner guidewire lumen within the balloon.The sheath was noted to be bent along its length and was buckled on the distal tip.During functional testing, an attempt was made to remove the balloon, but was unsuccessful, no further functional testing was performed due to the returned condition of the balloon which was bunched at the distal of the balloon, and a kink to the inner guidewire lumen and damaged sheath.Therefore, the investigation is confirmed for the reported sheath removal difficulties and identified material deformation as the distal tip of the balloon was noted to be bunched and core wires were bent and kink to the guidewire lumen which may have occurred due to difficulty during removal through the sheath.However, the investigation is inconclusive for the reported guidewire removal difficulty as no functional testing was performed due to the condition of the device returned.A definitive root cause for the reported sheath removal difficulty and guidewire removal difficulty 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.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) 2025, a patient underwent an angioplasty procedure using the ultrascore 014 in the superficial femoral artery via ipsilateral approach, the pta balloon catheter allegedly was stuck with the guidewire and could not be removed.It was further reported that the pta balloon catheter was allegedly stuck with the introducer sheath tip and could not be inserted into the introducer sheath and was removed together with the sheath.There was no reported patient injury.

• Brand Name: ULTRASCORE 014
• Common Device Name: FOCUSED FORCE PTA BALLOON
• 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: 22504098
• Report Number: 2020394-2025-01025
• Device Sequence Number: 8788782
• Product Code: PNO
• UDI-Device Identifier: 00801741114106
• UDI-Public: (01)00801741114106(11)230901(17)250728(10)GFHU0909
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172571
• 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
• Report Date (Section B): 07/11/2025

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: 07/28/2025
• Device Catalogue Number: US14150630
• Device Lot Number: GFHU0909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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