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

Catalog Number	BDRECANSYSTEM
Medical Device Problem Code	Problem with Software Installation (3013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the serial number for the device was provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided by bd represents all 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 the device could potentially be in the incorrect mode and recall was initiated to ensure all devices were tested.It was further reported that at this time, there are no alleged issues with the device.However, during evaluation the device was found to be in emc mode.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: this event is determined to be expected however a potential manufacturing related issue was identified; therefore, the device history records (dhr) were reviewed.The dhr review met all release criteria however the system was not reset to normal mode after system tests identified during dhr review.Investigation summary: the bd recanalization system was received for evaluation.The bd recanalization system was visually inspected upon receipt and was found to be in good overall condition.There were no visual defects observed.The device was functionally tested and failed the test as the unit was observed to be in emc mode identified during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the identified unit was in incorrect emc mode.The root cause for identified unit was in incorrect emc mode was determined to be manufacturing related.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.H10: g3, h6 (component, method).H11: d4 (unique identifier (udi) #), h6 (result, conclusion).H11: section a through f ¿ the information provided by bd represents all 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 the device could potentially be in the incorrect mode and recall was initiated to ensure all devices were tested.It was further reported that at this time, there are no alleged issues with the device.However, during evaluation the device was found to be in emc mode.There was no patient contact.

• Brand Name: CROSSER RECANALIZATION SYSTEM
• Common Device Name: RECANALIZATION SYSTEM
• 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: 20787082
• Report Number: 2020394-2024-01740
• Device Sequence Number: 7808854
• Product Code: PDU
• UDI-Device Identifier: 00801741202421
• UDI-Public: (01)00801741202421(11)210528
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K203363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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 Catalogue Number: BDRECANSYSTEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown