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

Model Number	US14150610
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery and the iliac artery via contralateral approach, the guidewire lumen and guidewire allegedly got stuck.It was further reported that the guidewire was allegedly difficult to remove.Reportedly, the guidewire lumen was found to be damaged.The balloon and guidewire were removed as one unit.There was no reported patient injury.
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 and unknown guide wire were returned for evaluation.No specific anomalies were noted on the catheter shaft, strain relief was moved to the center of the catheter and not seated properly.One of the core wires was noted to be broken/detached from the distal tip of the catheter and the inner guide wire lumen noted to be bunched.Dried blood residues noted throughout the guide wire lumen.No functional testing was performed due to condition of the device.All the anomalies noted on the microscopic observation.Therefore, the investigation for the reported difficult to remove and device-device incompatibility remains inconclusive as no functional testing has been performed due to the condition of the device.However, the investigation for the reported material deformation is confirmed, as the inner guide wire lumen noted to be bunched was able to be observed on the returned device.The investigation was also confirmed for an identified scoring wire break as one of the scoring wires was noted to be detached from the distal tip of the catheter.A definitive root cause for the reported difficult to remove ,device-device incompatibility ,material deformation and scoring wire break 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: 08/2023).

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13966079
• Report Number: 2020394-2022-00242
• Device Sequence Number: 5053745
• 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): 03/07/2022

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: GFFU3046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/31/2022
• 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