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

Catalog Number	SK15018
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a recanalization procedure, the catheter has been allegedly broken.It was further reported that the cone head falls off and separates from the catheter.Furthermore, the cone head still connected to the core.The procedure was completed by using another device.There was no patient contact.
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, a video and photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 01/2025).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.
Event or Problem Description
It was reported that prior to a recanalization procedure, the catheter has been allegedly broken.It was further reported that the cone head falls off and separates from the catheter.Furthermore, the cone head still connected to the core.The procedure was completed by using another device.There was no patient contact.
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 returned for evaluation.The complaint sample was received in two segments.A complete circumferential detachment was noted on the distal end of the strain relief.Segment two consists of the remaining catheter shaft which was stretched.No other anomalies were noted.Two photos and one video were reviewed.Both the images and video show the proximal portion of seeker is seen detached from the rest of the device which is in its protective hoop.Therefore, the investigation is unconfirmed for the reported material separation but confirmed for the identified detachment as the section of the catheter shaft was completely detached and also confirmed for the identified stretch as the detached proximal end of the catheter shaft was stretched.A definitive root cause for the alleged separation and identified detachment, stretch 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 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 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 AZ 85281
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20488942
• Report Number: 2020394-2024-01594
• Device Sequence Number: 11651158
• Product Code: DQY
• UDI-Device Identifier: 00801741067914
• UDI-Public: (01)00801741067914(17)250126(10)VTHN0689
• 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): 12/30/2024

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: 01/26/2025
• Device Catalogue Number: SK15018
• Device Lot Number: VTHN0689
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 10/19/2024
• Supplement Report FDA Received Date: 01/22/2025
• 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