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

Model Number	SK15035M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.Expiry date: 09/2024.
Event or Problem Description
It was reported that during a recanalization procedure, the tip of the device was allegedly detached.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: one seeker crossing support catheter was returned for evaluation.During visual evaluation, the tip was noted to be detached.Segment measures 149 cm from break to strain relief.No functional testing due to the condition of the device.One electronic photo was provided and reviewed.The photo shows the seeker package and label of the device.The product is not clearly visible in the provided photo.Therefore, based on the photo review, the investigation can not be confirmed for the reported detachment issue.One fluoroscopic image was provided and reviewed.The image showed the right thigh.Part of a wire is seen likely in the proximal superficial femoral artery.Distal to this is an object that resembles a piece of the catheter.The remaining portion of the catheter is not visualized.Therefore, based on the image review, the investigation is confirmed for the reported detachment issue.Therefore, the investigation is confirmed for detachment of device or device component issue as the tip was noted to be detached.A definitive root cause for the reported detachment issue could not be determined based upon the provided information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: b5, d4 (expiry date: 09/2024), g3, h6 (method).H11: section a through f - the information provided by bd represents all of 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, the tip of the device was allegedly detached.It was further reported that the detached part could not be retrieved by using snare.There was no reported patient injury.

• Brand Name: SEEKER
• 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: 15769091
• Report Number: 2020394-2022-00887
• Device Sequence Number: 15075531
• Product Code: DQY
• UDI-Device Identifier: 00801741067921
• UDI-Public: (01)00801741067921
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K103367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2023

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 Model Number: SK15035M
• Device Catalogue Number: SK15035M
• Device Lot Number: VTGW0047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 01/21/2023
• 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