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

Model Number	7266V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been opened to review device history record and risk documentation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: customer states that the stiffen micro introducer tip broke when needle was placed in it.Additional information received on 22-nov-2021: the procedure was a left heart catherization.The case was completed with another micro-introducer kit (same model).The current patient condition is reported as fine.Additional information received on 01-dec-2021: it was clarified by the account, that the sheath's tip is what broke on the micro-introducer kit.
Additional Manufacturer Narrative
One-unit of mik was returned for evaluation.Blood particulates were observed on the sheath.The manufacturer was notified of the complaint and a device history record review was requested.No non conformances were noted.All processes were followed without any deviation.The event description states "mik tip broke when the needle was placed in it.".The tip of the sheath was damaged with the polymer stretched at the distal tip.Approximately 4.3cm of the sheath was missing.A kink was observed on the lumen of the sheath.The damages are likely to have occurred during use in the procedure.Per ifu, states the following warning - 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.The stretching of the polymer indicates operation of sheath against resistance.Event statement is unclear as to why the needle was placed in the sheath.Per deployment procedure steps needle is removed once the guidewire is secured in the vessel.The sheath along with dilator is introduced leading to the removal of the dilator and securement of the sheath inside the vessel.Additional information was requested.No response of tip retrieval was received.Procedure was completed using another kit.Patient condition is fine.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.

• 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: angela meister ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564253
• MDR Report Key: 12938232
• Report Number: 2134812-2021-00073
• Device Sequence Number: 19987649
• Product Code: DYB
• UDI-Device Identifier: 10841156107086
• UDI-Public: 10841156107086
• Combination Product (Y/N): N
• 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): 11/08/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: 7266V
• Device Catalogue Number: 7266V
• Device Lot Number: 73F2100759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• 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: Other
• Patient Sex: Female