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

Model Number	7266V
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been opened and a follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: used the 4f microintroducer kit and it broke during use; able to retrieve all pieces, and no further surgical interventions needed to be done.Case was completed as usual.Surgeon was able to remove affected sheath over the wire and with the help of a hemostat recover all pieces.The procedure was completed without further incident.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.A picture was sent by the account confirming separation of a portion of the sheath.A manufacturer record review was completed.There were no nonconformances related to this lot were identified therefore supporting the device met material, assembly, and performance specifications.A patient underwent a tavr procedure.A mik unit was used for access.The mik broke during use.The lumen appears to be stretched indicating operation against resistance.Per ifu, a warning and precaution are stated as of the following: - never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the guidewire against resistance may result in separation of the guidewire tip, damage to the guidewire, or vessel perforation additional information was requested on vessel factors to determine if the sheath interacted with calcification or any other anatomical factor.A response was received.The vessel was not tortuous or calcified.It is unknown if the sheath interacted with any other ancillary devices that was used along with it leading to damages observed in the pictures.Device was retrieved using forceps.It is unknown if any other damages occurred on the sheath without product evaluation.Based on the information, the most likely root cause of the issue is undeterminable.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564300
• MDR Report Key: 12333731
• Report Number: 2134812-2021-00057
• Device Sequence Number: 4712625
• Product Code: DYB
• UDI-Device Identifier: 20841156107083
• UDI-Public: (01)20841156107083
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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 Model Number: 7266V
• Device Lot Number: 73C2100675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male