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

Catalog Number	SK15018
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2024
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 device has not been returned to the manufacturer for evaluation.However, 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.H3 other text : device not returned.
Event or Problem Description
It was reported that during a recanalization procedure in right femoral artery, the guidewire allegedly failed to pass through the support catheter.It was further reported that the guidewire allegedly poked out at the half-section of the support catheter.Reportedly, the support catheter was allegedly broken.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.Three photos were provided and reviewed.The first photo shows the seeker device within its packaging.The labeling matches with the information available in trackwise.The catheter shaft is seen completely detached in two segments.The second and third photos also show the catheter shaft of the device completely detached in two segments.Therefore, the investigation is unconfirmed for the reported break and material hole but confirmed for the identified detachment as the catheter shaft was seen completely detached.The investigation is also inconclusive for the reported device-device incompatibility as functional testing for the same could not be performed.A definitive root cause for the reported break, material hole, device-device incompatibility 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.H10: b5, d4 (expiration date: 01/2025), g3, h6 (device, method).H11: h6 (result, conclusion).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.H3 other text : device not returned.
Event or Problem Description
It was reported that during a recanalization procedure in the right femoral artery via the retrograde approach, the guidewire allegedly failed to pass through the support catheter.It was further reported that the guidewire allegedly got poked out at the half-section of the support catheter.Reportedly, the support catheter was allegedly broken.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: SEEKER CROSSING SUPPORT
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 18708711
• Report Number: 2020394-2024-00203
• Device Sequence Number: 7205184
• Product Code: DQY
• UDI-Device Identifier: 00801741067914
• UDI-Public: (01)00801741067914
• 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): 04/26/2024

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 Catalogue Number: SK15018
• Device Lot Number: VTHN0413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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