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

Model Number	7195V
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: physician tried to pull the wire from the needle, and the wire was shredded and he had to pull the whole thing out, and insert a nitinol wire.Medical intervention is reported as unknown.Procedure was reported to be completed with this device.Multiple attempt have been made to obtain additional information.
Additional Manufacturer Narrative
There was no product returned for this complaint.A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was not completed as the unit was not returned to teleflex.Multiple attempts were made to receive more information and device return, nothing was received from the account.Based on the limited information received it is likely that the wire was withdrawn through the needle causing the damage to the wire.The mik ifu warns; "do not withdraw the guidewire through the needle.If necessary, remove both the needle and guidewire as a unit to prevent the needle from damaging or shearing the guidewire.".

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10737771
• Report Number: 2134812-2020-00088
• Device Sequence Number: 3346016
• Product Code: DYB
• UDI-Device Identifier: 10841156102623
• UDI-Public: (01)10841156102623
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: 7195V
• Device Catalogue Number: 7195V
• Device Lot Number: 674980
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1