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

Catalog Number	US3513064
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
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 was performed.The return of the sample is pending.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 (b)(6) 2025, a patient underwent an angioplasty procedure using ultrascore 035 pta balloon.During the procedure, the pta balloon catheter allegedly could not be removed from sheath.It was further reported that the wire attached to the balloon was broke.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation review: one ultrascore 035 catheter was returned for evaluation in two segments.Upon visual inspection, the device was returned in two segments.Segment 1 consists of the y-body and proximal end of the catheter.The catheter had a break with the score wires extending out of the break.The catheter was stretched.Segment 2 consists of the distal end of the catheter with the balloon.Balloon was bloody and the catheter appeared to be stretched.Score wires were attached to the distal tip of the catheter, however the middle portion of the score wires were not returned.Due to the condition of the returned device functional testing could not be performed.Therefore, the investigation is confirmed for the identified detachment and reported sheath removal difficulty as the device was returned in two segments.Also, the scoring wires were found detached and stretching was noted on the shaft, which could have contributed to difficulty during sheath removal.The investigation is unconfirmed for the reported break as no break were noted to the returned device.A definitive root cause for the reported sheath removal difficulty, break and identified detachment 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.G2, g3, h6 (device, component, 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) 2025, a patient underwent an angioplasty procedure using ultrascore 035 pta balloon.During the procedure, the pta balloon catheter allegedly could not be removed from sheath.It was further reported that the wire attached to the balloon was broke.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRASCORE FOCUSED FORCE PTA BALLOON
• 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: 21934499
• Report Number: 2020394-2025-00643
• Device Sequence Number: 7985117
• Product Code: PNO
• UDI-Device Identifier: 00801741116841
• UDI-Public: (01)00801741116841(11)250214(17)280128(10)GFJZ0236
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: US3513064
• Device Lot Number: GFJZ0236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2025
• 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