MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRASCORE 014; PTA BALLOON DILATATION CATHETER

Model Number	US14150610
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
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 014 pta dilatation catheter was received for evaluation.During visual evaluation, the strain relief was noted to be dislodged from the y-body.No kinks were noted to the catheter shaft and no anomalies to the luers/y-body.During functional evaluation, the sample guidewire unable to be flushed.The patency of the guide-wire lumen was tested using a returned guidewire and was unable to be inserted all the way through.The catheter was stripped and under microscopic examination, dry blood was noted within the inner guidewire lumen.No other functional testing was performed.Therefore, the investigation is inconclusive for the reported guidewire removal issue as functional testing could not be performed due to dried blood within the guidewire lumen.However, the investigation is confirmed for the identified dislodged strain relief as the strain relief was noted to be dislodged from the y-body during visual evaluation.A definitive root cause for the reported guidewire removal issue and identified dislodged strain relief 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.(expiry date: 08/2024).
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery via a contralateral approach, the guidewire allegedly got stuck after inflating.It was further reported that the balloon and guidewire were removed together as one unit.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: ULTRASCORE 014
• 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: 16377981
• Report Number: 2020394-2023-00080
• Device Sequence Number: 12343951
• Product Code: PNO
• UDI-Device Identifier: 00801741114052
• UDI-Public: (01)00801741114052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/20/2023

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 Model Number: US14150610
• Device Catalogue Number: US14150610
• Device Lot Number: GFGU3109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/15/2023
• 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