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

Catalog Number	SK13518
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, prior to a recanalization procedure using a seeker catheter, the patient presented with aso in the left lower limb.A v18 guidewire was selected for recanalization, and a seeker stylet was used in conjunction with it.Upon deployment of the seeker catheter, a crease was observed on the distal portion of the catheter, preventing the v18 guidewire from passing through the distal tip.As a result, recanalization of the lesion could not be performed with the device.The guidewire was unable to pass through the distal tip.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H11: this supplemental report is submitted to correct an error in the previously submitted reports.The initial mdr is listed an incorrect manufacturing location (g1).The correct manufacturing location for this device is future matrix 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 product and lot.Investigation summary: received one seeker crossing support catheter.Upon visual evaluation, one seeker device was received for evaluation in two segments, along with product packaging.The first segment consists of the distal portion of the device, including the distal tip and marker.The second segment was the remaining portion of the catheter and hub.On functional testing, it appears the location of the break may have been the location of the reported kink, as flattening can be seen to the break end of each returned segment.No functional testing was performed due to the nature of the complaint.One electronic photo was received and reviewed.The photo shows a healthcare professional holding a seeker catheter, with a slight kink observed near the distal tip.Therefore, the investigation is confirmed for the reported material deformation as kink was noted on the catheter.Also, the investigation is confirmed for the identified detachment as device was returned in two segments.However, the investigation is inconclusive for the reported guidewire insertion as functional testing was not performed due to device returned condition.A definitive root cause for the reported material deformation, device device incompatibility and identified detachment issue 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 provide 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
• 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 75751
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50492798
• Report Number: 2020394-2026-02261
• Device Sequence Number: 21360025
• Product Code: DQY
• UDI-Device Identifier: 00801741067884
• UDI-Public: (01)00801741067884(17)270903(10)93WK0025
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: SK13518
• Device Lot Number: 93WK0025
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/22/2026
• 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