MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRASCORE 035; PTA BALLOON DILATATION CATHETER

Catalog Number	US35130515
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured during inflation.It was further reported that the pta balloon allegedly had rupture due to the connection between the catheter and plastic piece that connects to the balloon and wire port.Reportedly, the pta balloon was pulled out of the body and off the wire.There was no reported patient injury.
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 11/2024).
Additional Manufacturer Narrative
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 035 device was returned for evaluation.An in-house presto inflation device was used to inflate the balloon, and a leak was noted to the distal end of the strain relief.The strain relief was then removed, and water was noted from under the coils.However, the exact source of the leak could not be determined.No leak was noted to the balloon.One photo was provided and reviewed.The photo shows the ultrascore 035 device.The rubber strain relief is seen circled in the picture, referring to the area where the reported issue was mentioned.However, no specific evidence of any failure could be gathered from inspection of the circled area or the whole picture.Therefore, the investigation is unconfirmed for the reported catheter burst as no burst to the catheter was noted.However, the investigation is confirmed for the identified leak as a leak was observed from the strain relief, but its source could not be determined.A definitive root cause for the alleged catheter burst and identified leak 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.D4 expiration date: 11/2024.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 allegedly ruptured during inflation.It was further reported that the pta balloon allegedly had rupture due to the connection between the catheter and plastic piece that connects to the balloon and wire port.Reportedly, the pta balloon was pulled out of the body and off the wire.There was no reported patient injury.

• Brand Name: ULTRASCORE 035
• 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: 20294396
• Report Number: 2020394-2024-01470
• Device Sequence Number: 12793969
• Product Code: PNO
• UDI-Device Identifier: 00801741116797
• UDI-Public: (01)00801741116797
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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 Catalogue Number: US35130515
• Device Lot Number: GFGY0295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/04/2024
• 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 Sex: Unknown