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

Catalog Number	SK13518
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient prepped for a recanalization procedure.Prior to the procedure, it was reported that the tip of the seeker catheter allegedly fractured.The procedure was completed using another device.There was no patient contact.
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 return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.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: additional information was received, and the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.G3, h6 (device).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) 2025, a patient prepped for a recanalization procedure.Prior to the procedure, it was reported that the tip of the seeker catheter allegedly fractured.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be reportable.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one photo was provided and reviewed.The photo shows the distal end of the seeker which is noted to be partially broken but still attached to the shaft.One seeker crossing support catheter was received for evaluation.Upon visual evaluation, it was noted the device was received with a break near the distal tip proximal to the marker band from the distal tip.No anomalies noted to the hub.No functional testing was performed as the alleged failure was break.Therefore, the investigation is confirmed for the break as the break was noted to the shaft proximal to the marker band.A definitive root cause for the reported break 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, 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
On (b)(6) 2025, a patient prepped for a recanalization procedure.Prior to the procedure, it was reported that the tip of the seeker catheter allegedly fractured.The procedure was completed using another device.There was no patient contact.

• 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: 22910751
• Report Number: 2020394-2025-01359
• Device Sequence Number: 13023575
• Product Code: DQY
• UDI-Device Identifier: 00801741067884
• UDI-Public: (01)00801741067884(17)261219(10)93YJ0119
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2025

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: 93YJ0119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 09/30/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/12/2025; 10/22/2025
• 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
• Patient Sex: Unknown