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

Model Number	0244512
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
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: 06/2023).
Event or Problem Description
It was reported that the device pulled air while charging.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one true dilation pta dilatation catheter has returned for evaluation.On the visual evaluation the device appeared clean.The distal tip was not present on the returned device and the catheter tip appeared blunt.No anomalies were noted to the device.On the functional evaluation the device inflated with in-house presto device and the device maintain shape and pressure, however upon inflation water leaks from the distal end of the balloon.Microscopic observation was performed and noted the break at the balloon distal tip.No further testing performed.Therefore, the investigation for the reported inflation issue has confirmed as the as fluid is leaking out during inflation on the functional evaluation.The investigation has confirmed for the identified leak and break as the water leaks from the distal end of the balloon upon inflating the device.A definitive root cause for the alleged inflation issue and identified leak and break 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: 06/2023), g3, h6(device) ; h11: b5,h6(method, result, conclusion) ; 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 device allegedly failed to inflate.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: TRUE 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: 10799070
• Report Number: 2020394-2020-20352
• Device Sequence Number: 3931856
• Product Code: OZT
• UDI-Device Identifier: 00801741091018
• UDI-Public: (01)00801741091018
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 0244512
• Device Catalogue Number: 0244512
• Device Lot Number: GFET1776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 06/25/2021
• 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