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

Catalog Number UNK SEEKER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 01/07/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported through a post-market survey for support catheters that there were two occurrences of flow-limiting dissection which required intervention.The procedure was stopped and moved to bypass surgery at a later date.The current status of the patient(s) was not provided.

• Brand Name: SEEKER
• Type of Device: 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11271078
• MDR Text Key: 230018920
• Report Number: 2020394-2021-00113
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SEEKER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention