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

Model Number 7952

Device Problem Material Fragmentation (1261)

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

Event Date 06/26/2018

Event Type  Injury  

Manufacturer Narrative

A manufacturing record review was completed and zero nonconformances were found therefore supporting the device met material, assembly and performance specifications.A returned product evaluation was unable to be completed as no devices were returned for investigation.If further information is received, a follow-up report will be submitted.

Event Description

Wire tip kinked up and broke off when excessive force used while trying to insert grebset.Another physician removed the wire.Per medwatch (b)(4) received july 13, 2018: grebset micro-introducer kit being used.Guidewire in kit broke when trying to withdraw through trocar of kit.Broken wire was retained under skin.Intended procedure was a percutaneous nephrostomy tube placement.

• Brand Name: GREBSET
• Type of Device: GREBSET MICRO-INTRODUCER
• 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: 7772394
• MDR Text Key: 116748307
• Report Number: 2134812-2018-00052
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: M20679510
• UDI-Public: M20679510
• 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: 07/13/2018

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 Expiration Date: 04/18/2020
• Device Model Number: 7952
• Device Lot Number: 623393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• 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 Age: 55 YR
• Patient Weight: 76