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

Catalog Number	US35130512
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	07/19/2023
Type of Reportable Event	Malfunction
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 ultrascore 035 pta dilatation catheter was received for evaluation.During visual evaluation, no anomalies were noted to the luers/y-body.During functional evaluation, an in-house presto inflation device was used to inflate the balloon and water was noted leaking from the strain relief.The rubber strain relief was removed, and water was seen leaking from under the coils.Due to the position of the coils, the source of the leak was unable to be determined.Therefore, the investigation is inconclusive for the reported burst shaft but confirmed for the identified leak as water was noted leaking from the strain relief, but its source could not be determined.A definitive root cause for the alleged burst shaft 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.H10: d4 (expiration date: 01/2025) 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 in the left superficial femoral artery via the left femoral artery crossover approach, the shaft of the pta balloon allegedly seemed to be burst during the second inflation.It was further reported that upon investigation, a leakage at the shaft where the shaft was connected to the pressure syringe, was noted.The procedure was completed by using another device.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 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: 18090772
• Report Number: 2020394-2023-00999
• Device Sequence Number: 17809860
• Product Code: PNO
• UDI-Device Identifier: 00801741116780
• UDI-Public: (01)00801741116780
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172571
• 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
• Report Date (Section B): 11/08/2023

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: US35130512
• Device Lot Number: GFHN1619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 11/08/2023
• 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