MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Seeker Crossing Support Catheter

Catalog Number	SK15018
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a recanalization procedure using a seeker support catheter via femoral access.During the procedure, it was reported that the catheter ruptured while being advanced over a 0.018-inch guidewire.The catheter separated into two pieces.The procedure was subsequently completed using a competitor's catheter.No patient harm was reported, and there was no reported patient injury.
Additional Manufacturer Narrative
H11: this supplemental report is submitted to correct an error in the previously submitted reports.The initial mdr and supplemental report 2 listed an incorrect manufacturing location (g1).The correct manufacturing location for this device is futurematrix interventional.No new event information is being reported in this supplement.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: the physical device was not returned for evaluation.Two photos were provided and reviewed.First photo shows that the device seeker is been holding by the hcp in the detached condition.Second photo shows that the device and labelling details.Verified the same in the tw.Based on the photo review, the reported event can be confirmed.A definitive root cause for the detachment 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.G1, g3.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.

• Brand Name: Seeker Crossing Support Catheter
• Common Device Name: Support Catheter
• Manufacturer (Section D): Bard Peripheral Vascular, Inc.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): Futurematrix Interventional; 1605 enterprise street; athens AZ 75751
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50559113
• Report Number: 2020394-2026-02348
• Device Sequence Number: 13238960
• Product Code: DQY
• UDI-Device Identifier: 00801741067914
• UDI-Public: (01)00801741067914(17)271008(10)93XK0054
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K103367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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: SK15018
• Device Lot Number: 93XK0054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: 09/15/2026; 09/21/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/17/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown