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	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was returned to the servicing center due to a field action recall.During the servicing center¿s incoming inspection process, it was identified that the system was returned in the emc/vcp mode, rather than the normal mode.There was no patient contact.
Additional Manufacturer Narrative
H10: a device history record (dhr) and manufacturing review has been requested and pending completion.Upon receipt, the bd recanalization system was visually inspected and was found to be in normal condition.The device software was version 2.0.Functional testing was performed; however, the device did not pass as it was found to be in the emc/vcp manufacturing mode, rather than the normal mode designated for end users.The root cause for the functional test failure is related to a manufacturing processing error.In october 2023, bd issued a voluntary field action z-0676-2024 for this issue.To date there have been no adverse events worldwide reported related to this issue.As result of the field action, this event is being reported as a malfunction mdr.H10: d4 (expiration date: 08/2026).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.H3 other text : pending investigation completion.
Event or Problem Description
It was reported that the device was returned to the servicing center due to a field action recall.During the servicing center¿s incoming inspection process, it was identified that the system was returned in the emc/vcp mode, rather than the normal mode.There was no patient contact.
Additional Manufacturer Narrative
H10: in october 2023, bd issued a voluntary field action z-0676-2024 for this issue.To date there have been no adverse events worldwide reported related to this issue.As result of the field action, this event is being reported as a malfunction mdr.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 normal condition.Also, outdated software version 2.0 identified.The device was functionally tested and failed the test as the system was in incorrect 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: d4 (expiration date: 08/2026), g3, h6 (method).H11: 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.H3 other text : see h10.

• 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: 18857324
• Report Number: 2020394-2024-00324
• Device Sequence Number: 3313951
• Product Code: PDU
• UDI-Device Identifier: 00801741202421
• UDI-Public: (01)00801741202421
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 03/29/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0676-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown