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

Model Number 7941

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/07/2019

Event Type  Injury  

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 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.

Manufacturer Narrative

It is undeterminable what caused the separation or what component of the kit was reported to separate.

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
• Type of Device: GREBSET MICRO-INTRODUCER KIT,
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9410513
• MDR Text Key: 169063628
• Report Number: 2134812-2019-00076
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: M20679411
• UDI-Public: M20679411
• Combination Product (y/n): N
• PMA/PMN Number: K081846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 11/12/2019; 11/12/2019
• Supplement Dates FDA Received: 12/04/2019; 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other