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

Catalog Number	SK6535M
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
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.However, a image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 02/2025) 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 in the highly calcified artery, the device was allegedly sectioned during operation.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 highly calcified artery, the device was allegedly sectioned during operation.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: one photo was provided and reviewed.The photo shows the seeker device in its packaging.The labeling details match with the information available in trackwise.Complete detachment of a section near the distal part of the catheter is seen.Additionally, one xray image was provided and reviewed.The image shows a stent within an artery and a seeker catheter in several in the stent.There is no wire within the catheter, and it is presumed to have ¿sectioned.¿ there is a sheath with a wire inside of it.One seeker device was returned for evaluation.Complete circumferential detachment was noted at the distal end of the catheter shaft.No marker band was noted on the catheter shaft.Due to the nature of the complaint, no functional testing was performed.Therefore, the investigation is confirmed for the reported detachment as a section of the catheter is seen completely detached in both the provided images and the returned sample.A definitive root cause for the alleged 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: d4 (expiration date: 02/2025), g3.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.
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 device was returned for evaluation.Complete circumferential detachment was noted at the distal end of the catheter shaft.No marker band was noted on the catheter shaft.Due to the nature of the complaint, no functional testing was performed.One photo was provided and reviewed.The photo shows the seeker device in its packaging.The labeling details match with the information available in trackwise.Complete detachment of a section near the distal part of the catheter is seen.Additionally, one x-ray image was provided and reviewed.The image shows a stent within an artery and a seeker catheter in several in the stent.There is no wire within the catheter, and it is presumed to have 'sectioned¿.There is a sheath with a wire inside of it.Therefore, the investigation is confirmed for the reported detachment as a section of the catheter is seen completely detached in both the provided images and the returned sample.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3.H11: d4 (unique identifier (udi) #).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 during a recanalization procedure in the highly calcified artery, the device was allegedly sectioned during operation.The procedure was completed using another device.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: 19571313
• Report Number: 2020394-2024-00840
• Device Sequence Number: 8470388
• Product Code: DQY
• UDI-Device Identifier: 00801741067938
• UDI-Public: (01)00801741067938(17)250208(10)93PH0056
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2025

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 Expiration Date: 02/08/2025
• Device Catalogue Number: SK6535M
• Device Lot Number: 93PH0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 10/14/2024; 02/03/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 10/15/2024; 02/05/2025
• 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