MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER IQ ULTRASONIC; RECANALIZATION CATHETER

Catalog Number	XCTO146
Medical Device Problem Codes	Break (1069); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: received one crosser iq ultrasonic cto device for evaluation.Upon visual inspection, break was observed at the guidewire port, along with material separation between the distal tip and catheter sheath.The marker band was present, and slight damage was noted at the distal end of the catheter sheath; however, the inner guidewire lumen was not exposed.Functional testing using an in-house guidewire demonstrated smooth advancement and retraction without resistance when inserted from both the distal tip and the fractured guidewire port, exiting through the alternate end in each case.Therefore, the investigation is inconclusive for the reported incompatibility issue as functional testing could not be performed by inserting the guidewire into the distal tip.The investigation is confirmed for the identified break was observed to the guidewire port.The investigation is confirmed for the identified material separation between the distal tip and catheter sheath and also the investigation is confirmed for the identified material deformation at distal end of the catheter sheath.The investigation is confirmed for the reported improper or incorrect procedural method as the user performed the procedure not per ifu.A definitive root cause for the reported guidewire incompatibility could not be determined based upon the provided information.A definitive root cause for the identified break, material deformation and material separation 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.Section a through f: the information provided by bd represents all of 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
On (b)(6) 2026, a patient underwent a recanalization procedure using the crosser catheter.During the procedure, after passing through the wire vassallo support in a right cfa calcified lesion via a left contralateral approach, the patient attempted to insert the wire into the crosser iq, but the guidewire was reluctant to go in at all, and there was no way to get the wire caught in the guidewire port and no way to get the wire out.The procedure was successfully completed using another device.There was no reported patient injury.

• Brand Name: CROSSER IQ ULTRASONIC
• Common Device Name: RECANALIZATION 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: 25423276
• Report Number: 2020394-2026-01475
• Device Sequence Number: 10119237
• Product Code: PDU
• UDI-Device Identifier: 00801741201332
• UDI-Public: (01)00801741201332(11)250926(17)280828(10)GFKU1891
• 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): 06/03/2026

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: GFKU1891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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