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

Catalog Number	TF0203511
Medical Device Problem Codes	Inflation Problem (1310); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
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 is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.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
It was reported that during a valvuloplasty procedure, the ptv balloon allegedly failed to progress.It was further reported that the balloon allegedly did not expand during insufflation.The procedure was completed using another device.There was no reported patient injury.
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: the physical device was not returned for evaluation.One photo was received and reviewed.The photo shows the trueflow device placed inside the protective hoop with the labeling details matched with details in trackwise.No other anomalies were noted.Therefore, the investigation is inconclusive for the reported inflation issue as no objective evidence was provided for review.A definitive root cause for the reported inflation issue 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 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
It was reported that during a valvuloplasty procedure, the ptv balloon allegedly did not expand during insufflation.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: TRUE FLOW DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• 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: 20565129
• Report Number: 2020394-2024-01634
• Device Sequence Number: 7459644
• Product Code: OZT
• UDI-Device Identifier: 00801741097652
• UDI-Public: (01)00801741097652(17)250428(10)GFHQ1487
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K172932
• 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): 11/18/2024

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: 04/28/2025
• Device Catalogue Number: TF0203511
• Device Lot Number: GFHQ1487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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