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

Catalog Number	CRUS106
Medical Device Problem Codes	Material Separation (1562); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a recanalization procedure, the catheter was allegedly stick to the wire.It was further reported that the wire access was lost while trying to retrieve the device.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 crosser device was returned for evaluation.The 14s crosser cto recanalization catheter was returned loaded onto an unknown brand guidewire.A dry saline residue was noted at the distal end of the catheter shaft.Partial material separation was noted at the distal end of the catheter.The sample guide-wire lumen was flushed successfully.A measurement of the returned guidewire was taken and noted, the patency of the unknown guide-wire lumen was used and able to be inserted without any resistance and also retracted without issue.An in-house pin gauge was inserted into the distal tip of the catheter and no issues were noted.No other further testing was performed.Therefore, the investigation is unconfirmed for the reported device-device incompatibility through the evaluation of the unknown guide wire, as the sample guide-wire lumen was flushed successfully.A measurement of the returned guidewire was taken and noted, the patency of the unknown guide-wire lumen was used and able to be inserted without any resistance and also retracted without issue.An in-house pin gauge was inserted into the distal tip of the catheter and no issues were noted.However, the investigation is confirmed for the identified material separation as the partial separation was noted at the distal end of the catheter.A definitive root cause for the reported guidewire incompatibility and identified separation could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: 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
• 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: 21231529
• Report Number: 2020394-2025-00022
• Device Sequence Number: 11827763
• Product Code: PDU
• UDI-Device Identifier: 10801741125635
• UDI-Public: (01)10801741125635(17)260428(10)GFJP0510
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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 Expiration Date: 04/28/2026
• Device Catalogue Number: CRUS106
• Device Lot Number: GFJP0510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/24/2025
• 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: Female
• Patient Race: White