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

Catalog Number	CRUO14SA
Medical Device Problem Codes	Material Separation (1562); Material Twisted/Bent (2981); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
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 14s crosser cto recanalization catheter was received for evaluation.During visual evaluation, no anomalies were noted to transducer handle, saline hub.The marker band was present without damage.During functional testing, the crosser was connected to the crosser generator and flow mate injector without issue.It was then loaded onto an in-house sheath crosser fixture without issue.The distal tip of the catheter shaft was pressed against the end of a plaster tile.The device activated and was not able to penetrate the tile due to twisting noted at the distal portion.The device did not exhibit misting, and no leaks were noted.After removal, under microscopic observation, material separation was noted on the distal tip of the catheter.No abnormal noises were heard.Therefore, the investigation is confirmed for the reported activation problem as the device could not penetrate the plaster tile.Also, the investigation is confirmed for the identified twist and material separation as twisting was noted at the distal portion of the device and separation was noted at the distal tip.A definitive root cause for the reported activation problem and identified material separation, twist 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.
Event or Problem Description
It was reported that during a recanalization procedure in the superficial femoral artery, the device allegedly had a chirp vibration.The procedure was completed treat with angioplasty and stent.There was no reported patient injury.

• 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: 21615734
• Report Number: 2020394-2025-00338
• Device Sequence Number: 8426019
• Product Code: PDU
• UDI-Device Identifier: 10801741125598
• UDI-Public: (01)10801741125598(17)250528(10)GFHS1400
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/13/2025

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: 05/28/2025
• Device Catalogue Number: CRUO14SA
• Device Lot Number: GFHS1400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/17/2025
• 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 Age: 80 YR
• Patient Sex: Male
• Patient Race: Black Or African American