MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. True Flow Dilatation Catheter; PTA Balloon Dilatation Catheter

Catalog Number	TF0203511
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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) 2026, a patient underwent a valvuloplasty procedure using the true flow balloon.During balloon removal, resistance was encountered, and the balloon was noted to be slightly deformed.The procedure was completed without removal of the kevlar protective layer.There was no reported patient injury.
Event or Problem Description
On (b)(6)2026, a patient underwent a valvuloplasty procedure using the true flow balloon.During balloon removal, resistance was encountered, and the balloon was noted to be slightly deformed.The procedure was completed without removal of the kevlar protective layer.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2026, a patient underwent a valvuloplasty procedure using the true flow balloon.During balloon removal, resistance was encountered, and the balloon was noted to be slightly deformed.The outer kevlar protective layer was seen on the balloon.The outer layer was removed after the balloon had been removed from the patient.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 summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported sheath removal difficulty and material deformation as no objective evidence was provided for review.However, the investigation is confirmed for the reported incorrect procedure issue as the reported event states, the balloon protector was removed only after the device was used which was against the instructions for use.A definitive root cause for the reported difficult to remove and deformation could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.D4 (unique identifier (udi) #), g3, h6 (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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported sheath removal difficulty and material deformation as no objective evidence was provided for review.However, the investigation is confirmed for the reported incorrect procedure issue as the reported event states, the balloon protector was removed only after the device was used which was against the instruction for use.A definitive root cause for the reported difficult to remove and deformation could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.B5, g3.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.

• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25751326
• Report Number: 2020394-2026-01767
• Device Sequence Number: 21483618
• Product Code: OZT
• UDI-Device Identifier: 00801741097652
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K172932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

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: TF0203511
• Device Lot Number: GFLN0831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: Not provided; 09/23/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 09/03/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2026
• 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