MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. Seeker; Support Catheter

Catalog Number	SK9035M
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: 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.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.
Event or Problem Description
On (b)(6) 2026, a patient underwent a recanalization procedure using the seeker catheter.During the procedure, the catheter was allegedly separated into two pieces.Furthermore, open surgery was performed to remove the part of the catheter that broke off in the patient.The current status of the patient is unknown.
Event or Problem Description
On (b)(6) 2026, a patient underwent a recanalization procedure using a seeker catheter.During the procedure, the tip of the catheter split and separated into two pieces, with a portion becoming lodged in the patient.Furthermore, open surgery was performed to remove the part of the catheter that broke off in the patient.The current status of the patient is unknown.
Event or Problem Description
On (b)(6)2026, a patient underwent a recanalization procedure using a seeker catheter.During the procedure, the tip of the catheter split and separated into two pieces, with a portion becoming lodged in the patient.Furthermore, open surgery was performed to remove the part of the catheter that broke off in the patient.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: received one seeker crossing support catheter.Upon visual evaluation, the seeker crossing support catheter was received in two segments.Segment one consists of the catheter hub and strain relief.A complete circumferential break was noted on the stretched catheter shaft portion at the distal end.Segment two consists of the remaining catheter shaft.A complete circumferential break was noted on the proximal end of the catheter shaft that was noted to be stretched.The distal tip of the catheter shaft segment was noted to be deformed.No other anomalies were observed.Due to complaint received in two segments, no functional testing was performed.Therefore, the investigation is confirmed for the reported detachment of device or device component as the catheter was received in two segments.Also, the investigation is confirmed for the identified material deformation as the distal tip of the catheter shaft segment was noted to be deformed.A definitive root cause for the reported detachment and identified deformation 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.G3, h6 (device, component, method, result, conclusion).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.
Additional Manufacturer Narrative
H11: this supplemental report is submitted to correct an error in the previously submitted reports.The initial mdr and supplemental report 1 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: received one seeker crossing support catheter.Upon visual evaluation, the seeker crossing support catheter was received in two segments.Segment one consists of the catheter hub and strain relief.A complete circumferential break was noted on the stretched catheter shaft portion at the distal end.Segment two consists of the remaining catheter shaft.A complete circumferential break was noted on the proximal end of the catheter shaft that was noted to be stretched.The distal tip of the catheter shaft segment was noted to be deformed.No other anomalies were observed.Due to complaint received in two segments, no functional testing was performed.Therefore, the investigation is confirmed for the reported detachment of device or device component as the catheter was received in two segments.Also, the investigation is confirmed for the identified material deformation as the distal tip of the catheter shaft segment was noted to be deformed.A definitive root cause for the reported detachment and identified deformation 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
• 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: 25369967
• Report Number: 2020394-2026-01433
• Device Sequence Number: 10655248
• Product Code: DQY
• UDI-Device Identifier: 00801741067952
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K103367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SK9035M
• Device Lot Number: 93VK0064
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 08/03/2026; 09/21/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 08/06/2026; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown