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

Catalog Number	XCTO146
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient underwent a recanalization procedure using the crosser iq catheter for treatment of a calcified lesion.During the procedure, approximately four minutes into use, it became difficult to cross the lesion.Upon pulling the device back, the tip of the device detached.As the patient is not fit for open surgery at that stage, the tip remained embedded in the calcified vessel.The procedure was not completed.The surgeon is following up with the patient for another surgery.The patient was later discharged.
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.

• 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: 50928868
• Report Number: 2020394-2026-02929
• Device Sequence Number: 13138797
• Product Code: PDU
• UDI-Device Identifier: 00801741201332
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: XCTO146
• Device Lot Number: GFKY1254
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown