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

Model Number	7941
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.A manufacturing record review was completed and no related nonconformances were found, no nonconformances were related to this lot, therefore supporting the device met material, assembly and performance specifications.Based on the lack of information received, it is undeterminable what caused the separation.A follow-up report will be submitted if additional information is received.
Event or Problem Description
Grebset model 7941 broke off during a procedure.Part of the grebset is still in the patient.Multiple attempts were made to obtain further information, however, unsuccessful.
Additional Manufacturer Narrative
It is undeterminable what caused the separation or what component of the kit was reported to separate.
Additional Manufacturer Narrative
One unit model: 7941 grebset guidewire was returned to vsi for evaluation.A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.The distal coil section of the wire was completely separated from the distal weld to the proximal bond.No other damage was found to the wire.Based on the lack of information received it is undeterminable what caused the separation.

• Brand Name: GREBSET
• Common Device Name: GREBSET MICRO-INTRODUCER KIT,
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9410513
• Report Number: 2134812-2019-00076
• Device Sequence Number: 14185547
• Product Code: DQO
• UDI-Device Identifier: M20679411
• UDI-Public: M20679411
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2019

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: No Information
• Device Expiration Date: 06/03/2021
• Device Model Number: 7941
• Device Lot Number: 650346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 11/12/2019; 11/12/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 12/04/2019; 01/09/2020
• 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: Other