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

Catalog Number	SK15018
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
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 return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 01/2025).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.
Event or Problem Description
It was reported that during a recanalization procedure in the occluded lower limb artery, the catheter allegedly broke during the flushing.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a recanalization procedure in the occluded lower limb artery, the catheter allegedly broke during the flushing.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Two photos and two videos were provided and reviewed.The first photo shows the seeker device in its packaging.The labeling details match with the information available in trackwise.The second photo and both the videos show a complete detachment of a portion of the seeker catheter around the fifth radiopaque marker from the distal tip.Therefore, the investigation is unconfirmed for the reported break but confirmed for the identified detachment as a section of the catheter is seen completely detached in the provided photos and videos.A definitive root cause for the alleged break and identified detachment 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.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.

• 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): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19636875
• Report Number: 2020394-2024-00946
• Device Sequence Number: 15238218
• Product Code: DQY
• UDI-Device Identifier: 00801741067914
• UDI-Public: (01)00801741067914(17)250112(10)93NH0099
• 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): 10/24/2024

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 Expiration Date: 01/12/2025
• Device Catalogue Number: SK15018
• Device Lot Number: 93NH0099
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/24/2024
• 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