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

Catalog Number	SK15035M
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a recanalization procedure, approximately four centimeters of the tip of the catheter was allegedly found to be broken off upon removal of the catheter.Reportedly, a snare was used to remove the broken segment through the same access site.There was no reported patient injury.
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 photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2025).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 contralateral iliac, approximately four centimeters of the tip of the catheter was allegedly found to be broken off upon removal of the catheter.Reportedly, a snare was used to remove the broken segment through the same access site.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: received one seeker crossing support catheter for evaluation.The sample appeared to have blood residue throughout.The sample was received in two segments.The segment one consists of the proximal end of the seeker catheter and segment two consisted of the remaining distal end of the seeker catheter.A complete circumferential break was noted to the catheter shaft.A kink was noted to the second segment.The functional testing is not performed due to the nature of the complaint.Also, one electronic photo was provided and reviewed.In that photo, the device is placed into the package.And also, the labelling information was provided on the same photo which verifies/matches with the track wise details.Therefore, the investigation is confirmed for the reported detachment as a circumferential break was noted to the catheter shaft and investigation is confirmed for the identified material deformation as a kink was noted to the second segment.A definitive root cause for the reported break and identified material deformation 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.(expiry date: 03/2025), g3.(device, method, result, conclusion) 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 contralateral iliac, approximately four centimeters of the tip of the catheter was allegedly found to be broken off upon removal of the catheter.Reportedly, a snare was used to remove the broken segment through the same access site.There was no reported patient injury.
Additional Manufacturer Narrative
Our firm received an fda email correspondence on 8-july-2024 from mdr data systems team, (b)(6), indicating that the information (specifically the unique device identifier (udi) information in section d) of the previously submitted fda form 3500a, was incorrect and a request was made to submit supplemental report(s) with the entire udi number including the di and pi fields, all numbers, letters, parentheses, and symbols in the ¿unique device identifier (udi) #¿ fields.This supplemental report is in response to that request.H11: d4: medical device expiration date- 03/29/2025.D4: udi- (b)(4).H4: device manufacture date- 03/29/2023.

• Brand Name: SEEKER
• Common Device Name: CROSSING 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: 18043944
• Report Number: 2020394-2023-00957
• Device Sequence Number: 7500250
• Product Code: DQY
• UDI-Device Identifier: 00801741067921
• UDI-Public: (01)00801741067921(11)230329(17)250329(10)93QH0188
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/16/2024

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: 03/29/2025
• Device Catalogue Number: SK15035M
• Device Lot Number: 93QH0188
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 02/05/2024; 07/08/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 02/10/2024; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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: Female