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

Model Number	7952
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: GREBSET MICRO-INTRODUCER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7772394
• Report Number: 2134812-2018-00052
• Device Sequence Number: 11110682
• Product Code: DQO
• UDI-Device Identifier: M20679510
• UDI-Public: M20679510
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K081846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2020
• Device Model Number: 7952
• Device Lot Number: 623393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 76