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

Model Number 8403

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

A returned product evaluation was completed and confirmed the complaint received; the radiopaque loop was separated from the device and the loop coils were unraveled.Based on the observed tensile break, the most likely root cause can be related to the tensile strength of the wire being exceeded.It is likely that the physician caught and pulled the snare loop in such a way that excessive force was exerted on the snare wire at the location of the separation.A manufacturing record review was completed and zero nonconformances were found, thus supporting that the device met material, assembly, and performance specifications prior to shipment.

Event Description

Physician was using expro snare to remove an ivc filter.Snare broke and piece remained inside patient; removed with another device.Additional info rec'd 18sep2018: per physician, helical portion of snare unscrewed from catheter when spun to capture ivc hook.What was left in patient was removed with an endobrachial forceps.Current patient condition is reported as fine.

• 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: 7956488
• MDR Text Key: 123399637
• Report Number: 2134812-2018-00072
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163307
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2020
• Device Model Number: 8403
• Device Lot Number: 602448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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
• Patient Weight: 98