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

Catalog Number	US14150510
Medical Device Problem Codes	Failure to Advance (2524); Device-Device Incompatibility (2919); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
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: one ultrascore 014 pta dilatation catheter was returned for evaluation.Dried saline was noted throughout the balloon and no other specific anomalies were noted during the visual evaluation.On functional testing, the guide wire lumen was flushed and an in-house guide wire was attempt to pass through the catheter lumen, however it didn¿t pass further near the proximal marked band.Then, the balloon was cut and under the microscope a tear on the guide wire lumen was noted near the proximal end of the balloon.No other functional testing performed.As the condition of use couldn¿t be replicated under the laboratory conditions for the reported lesion crossing difficulty and during the functional testing the in-house guide wire was unable to pass through the lumen due to the tear noted on the inner guide wire lumen, which observed during the microscopic observation.Therefore, the investigation remains inconclusive for the reported unable to cross lesion, but the investigation is confirmed for the identified guide wire advancement issue and identified inner guide wire lumen tear.A definitive root cause for the reported unable to cross lesion, identified guide wire advancement issue and identified inner guide wire lumen tear 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.H10: d4 (expiration date: 05/2024).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, the pta balloon was allegedly unable to cross the lesion.There was no reported patient injury.

• Brand Name: ULTRASCORE 014
• Common Device Name: PTA BALLOON DILATATION CATHETER
• 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: 18108858
• Report Number: 2020394-2023-01000
• Device Sequence Number: 7891374
• Product Code: PNO
• UDI-Device Identifier: 00801741113956
• UDI-Public: (01)00801741113956
• 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): 11/06/2023

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: US14150510
• Device Lot Number: GFGS1755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 78 YR
• Patient Sex: Male