MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Crosser iQ Ultrasonic; Recanalization Catheter

Catalog Number	XCTO146
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a recanalization procedure using a crosser iq catheter for the treatment of a highly calcified popliteal lesion.During the procedure, just before reaching the lesion, the guidewire was retracted approximately 1 cm into the catheter, and the device was activated.While advancing through the highly calcified popliteal lesion in the presence of vessel tortuosity, difficulty with device tracking was encountered.After approximately 4 minutes of operation, an abnormality was observed under fluoroscopy.A fracture was identified in the core wire connected to the titanium tip, and the device was immediately withdrawn.It was further reported that the titanium tip did not separate and remained attached to the catheter.The procedure was subsequently completed using alternative methods.Due to a patient infection, this device could not be retrieved.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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.

• Brand Name: Crosser iQ Ultrasonic
• Common Device Name: Recanalization 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50706842
• Report Number: 2020394-2026-02512
• Device Sequence Number: 18801727
• Product Code: PDU
• UDI-Device Identifier: 00801741201332
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: XCTO146
• Device Lot Number: GFKW1963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2025
• 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