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

Catalog Number	SK13514
Medical Device Problem Codes	Peeled/Delaminated (1454); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a recanalization procedure using a seeker crossing support catheter for the treatment of a calcified superficial femoral artery (sfa) lesion via a contralateral approach.During the procedure, it was reported that the guidewire could not be advanced through the distal tip of the catheter.After multiple attempts, the guidewire was successfully advanced; however, difficulty was subsequently encountered during withdrawal of the guidewire through the distal tip.Upon removal, flaking of the guidewire's polymer coating was observed.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 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.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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: 50559365
• Report Number: 2020394-2026-02350
• Device Sequence Number: 21309535
• Product Code: DQY
• UDI-Device Identifier: 00801741067877
• UDI-Public: (01)00801741067877(17)270701(10)93TK0181
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: SK13514
• Device Lot Number: 93TK0181
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/02/2026
• 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