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

Model Number	TF0223512
Medical Device Problem Codes	Flushing Problem (1252); Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 11/2022).
Event or Problem Description
It was reported that prior to the treatment the catheter allegedly had a hole.It was further reported that the balloon allegedly failed to flush.There was no patient contact.
Event or Problem Description
It was reported that prior to the treatment the catheter allegedly had a hole.It was further reported that the balloon allegedly failed to flush.There was no patient contact.
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 true flow valvuloplasty perfusion catheter has been received for the evaluation.On the visual evaluation, the device appeared clean and the balloon was partially inflated.No other specific anomalies were noted.On the functional evaluation, the guidewire lumen of the catheter was flushed using an in-house syringe and the water was able to successfully exit out of the distal tip.Then the in-house guidewire was advanced from the distal tip to exit out of the guidewire port.The balloon was then inflated using an in-house presto inflation device and the water starts exiting from the distal tip of the catheter.On further the guidewire was removed, the balloon was then inflated, once again the water exited out from the distal tip and the balloon could not be inflated to 3 atm.Then the catheter tip was clamped and inflated again and this time water exiting from the guide wire hub.Under the microscopic observation, the catheter shaft and the y- body was inspected and no holes or cracks were identified.The investigation for the reported failure to flush was unconfirmed as the guidewire lumen was flushed and the water successfully exited out of the distal tip during the evaluation.The investigation for the identified inflation issue was confirmed for, as the balloon was noted to have inflation issue during the evaluation.A definitive root cause for the reported failure to flush and the identified inflation issue could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 11/2022), g3.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.

• Brand Name: TRUE FLOW DILATATION CATHETER
• Common Device Name: VALVULOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11600654
• Report Number: 2020394-2021-00759
• Device Sequence Number: 4205800
• Product Code: OZT
• UDI-Device Identifier: 00801741097669
• UDI-Public: (01)00801741097669
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K152613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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 Model Number: TF0223512
• Device Catalogue Number: TF0223512
• Device Lot Number: GFEX2028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR