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

Catalog Number	US14150515
Medical Device Problem Codes	Material Puncture/Hole (1504); Difficult to Remove (1528); Material Rupture (1546); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
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 ultrascore 014 was returned for evaluation.Kinks and bunching were noted to the balloon.Kinks were also noted to the distal end of the balloon.A hole was identified in the catheter shaft.The guidewire protruded through the catheter shaft at the distal end.Bunching was noted to the inner guidewire lumen.Additionally, a compound rupture was noted to the balloon from the distal tip.Due to the presence of hole, functional testing could not be performed.No further testing was performed.Therefore, the investigation is inconclusive for the reported guidewire removal difficulty as functional testing could not be performed.However, the investigation is confirmed for the identified material hole and material deformation as a hole and bunching were noted to the balloon.Also, the investigation is confirmed for the identified balloon rupture as a compound rupture was noted to the balloon.A definitive root cause for the reported guidewire removal difficulty, identified material hole, material deformation and compound balloon rupture 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 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 that during an angioplasty procedure in the superficial femoral artery, the wire allegedly got stuck and could not be pulled out.Reportedly, the entire device was removed and a new wire was inserted.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 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: 20922422
• Report Number: 2020394-2024-01808
• Device Sequence Number: 20930266
• Product Code: PNO
• UDI-Device Identifier: 00801741113970
• UDI-Public: (01)00801741113970(11)230114(17)241228(10)GFGY2482
• 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): 12/10/2024

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: 12/28/2024
• Device Catalogue Number: US14150515
• Device Lot Number: GFGY2482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2023
• 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