MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SK9018; SEEKER CROSSING SUPPORT CATHETER

Model Number SK9018

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation could not identify a break or device-device incompatibility issue.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model sk9018 support catheter allegedly experienced device-device incompatibility and a break.This information was received from one source.This information was received from one source.The malfunction involved one patient with no patient consequences.The age, weight, and gender of the patient were not provided.

• Brand Name: SK9018
• Type of Device: SEEKER 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: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9963896
• MDR Text Key: 189203742
• Report Number: 2020394-2020-02730
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741067945
• UDI-Public: (01)00801741067945
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SK9018
• Device Catalogue Number: SK9018
• Device Lot Number: VTCV0299
• Date Manufacturer Received: 03/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1