MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC GREBSET; GREBSET MICRO-INTRODUCER KIT

Model Number 7952

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

Information was provided and the md was aware the issue could happen because he was using a chiba beveled tip needle.A manufacturing record review was completed and zero nonconformances were found.The returned product evaluation confirmed that the wire was broken, but it did not separate.The most likely root cause for the failure is damage during use.

Event Description

Wire in this kit came apart during the case.No sheath was in yet just wire in patient.Md was aware issue could occur because he was using a chiba beveled tip needle.Wire was retrieved by using the dilator of a micro introducer kit, backloaded and removed wire through dilator.

• Brand Name: GREBSET
• Type of Device: GREBSET MICRO-INTRODUCER KIT
• 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: 7006207
• MDR Text Key: 91228525
• Report Number: 2134812-2017-00089
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: 7952
• Device Lot Number: 611425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention