MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC EXPRO ELITE SNARE

Model Number 6600-015

Device Problem Detachment Of Device Component (1104)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

This event occured in (b)(6).Per us: similar device identified as: brand name: expro elitre snare.Common-device name: snare.The 510(k) 071457.One expro elite snare was returned to vsi for evaluation.The loop coil had broken just distal to the intact joint coil.As no non-conformities were found in the manufacturing records and the most likely root cause is excessive force applied by the user, no corrective action is required.

Event Description

Physician tried to catch a line of port catheter with expro elite snare, by doing this the tip of the snare was lost in the body of the patient.The catheter was retrieved and tip of snare was left in patient.Patient recovered without symptoms.Percutaneous intervention was performed.

• Brand Name: EXPRO ELITE SNARE
• Type of Device: SNARE
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 6649676
• MDR Text Key: 77843658
• Report Number: 2134812-2017-00057
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K0714757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 6600-015
• Device Lot Number: 581242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2015
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention