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

Catalog Number	XCTO146
Medical Device Problem Codes	Material Separation (1562); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
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 evaluation and microscopic visual observation.No anomalies noted to transducer handle and saline hub.The marker band is present and did not appear damaged.Material separation was noted between the distal tip and catheter sheath.Damage was noted on the distal end of the catheter sheath.The inner guidewire lumen was exposed and still attached to the catheter sheath.Due to the received condition of the device, no functional testing was performed.The investigation is inconclusive for the reported device device incompatibility as no functional testing was performed.The investigation is confirmed for the identified material separation between the distal tip and catheter sheath, and the investigation is confirmed for the identified material deformation on the distal end of the catheter sheath.A definitive root cause for the reported device-device incompatibility, identified material deformation and material separation could not be determined based on the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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, the patient underwent a recanalization procedure using the crosser iq catheter.Prior to the procedure, the guidewire allegedly failed to advance over the guide wire lumen.The procedure was completed using another device.There was no patient contact.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 25345885
• Report Number: 2020394-2026-01403
• Device Sequence Number: 21378300
• Product Code: PDU
• UDI-Device Identifier: 00801741201332
• UDI-Public: (01)00801741201332(11)251113(17)281028(10)GFKW0868
• 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): 05/28/2026

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: GFKW0868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• 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