MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SEEKER CROSSING SUPPORT; SUPPORT CATHETER

Catalog Number	SK15018
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a recanalization procedure, the support catheter was allegedly disconnected during withdrawal.It was further reported that the catheter was broken and lagging in the artery.Reportedly, the anterior tibial artery was narrowed, so the interventional device could not pass through, and it could only be removed surgically, and the operation was terminated after opening the posterior tibial and peroneal arteries.However, the current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos/images were provided for review.The investigation of the reported event is currently underway.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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.Two electronic photos, one xray image and video were provided and reviewed.The photos show the seeker catheter, which was noted to detached near the distal portion, but the detached portion is not returned.The xray image demonstrates a wire and catheter in the posterior tibial artery.The wire is curled back on itself.There is a catheter in the anterior tibial artery that is not on a wire and appears disconnected with the tip being proximal to a marker.The video is short demonstrating the catheter in the anterior tibial artery with another catheter and wire in the peroneal artery.There is some contrast enhancement of the peroneal artery with no contrast in the anterior tibial artery.Therefore, the investigation is confirmed for the reported detachment as detachment was noted in the distal end of the seeker.However, the investigation is inconclusive for the reported retraction problem as no objective evidence was provided.A definitive root cause for the alleged detachment and retraction problem 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.D4 (unique identifier (udi) #), g2, g3, h6 (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.
Event or Problem Description
A patient underwent recanalization procedure using seeker crossing support.During a recanalization procedure, the support catheter was allegedly disconnected during withdrawal.It was further reported that the catheter was broken and lagging in the artery.Reportedly, the anterior tibial artery was narrowed, so the interventional device could not pass through, and it could only be removed surgically, and the operation was terminated after opening the posterior tibial and peroneal arteries.The current status of the patient is unknown.

• 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): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21570056
• Report Number: 2020394-2025-00303
• Device Sequence Number: 8431121
• Product Code: DQY
• UDI-Device Identifier: 00801741067914
• UDI-Public: (01)00801741067914(11)231102(17)251101(10)93YH0022
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• Device Catalogue Number: SK15018
• Device Lot Number: 93YH0022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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