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

Model Number SK9035M

Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2022

Event Type  malfunction  

Event Description

It was reported that prior to a recanalization procedure, the last four inches of the catheter between the markers allegedly separated after removing it from the plastic hoop to flush.The procedure was completed using another device.There was no patient contact.

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: one seeker crossing support catheter was received and evaluated.On visual evaluation, the sample was returned into two segments.The two segments of the catheter were the hub and rest of the shaft.A complete circumferential break was noted to the catheter.Therefore, based on the findings, the investigation is confirmed for the identified detachment issue as the catheter detached.The investigation is inconclusive for the reported device damaged prior to use as no evidence was provided for review.A definitive root cause for the reported device damaged prior to use and the identified detachment issues could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Device expiry date: 09/2024.

• Brand Name: SEEKER
• Type of Device: 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: 16483410
• MDR Text Key: 311241596
• Report Number: 2020394-2023-00138
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SK9035M
• Device Catalogue Number: SK9035M
• Device Lot Number: VTGW0299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1