MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. MICRO-INTRODUCER; INTRODUCER CATHETER

Model Number	7267V
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found.The returned product evaluation confirmed the damage to the introducer.The introducer shaft was severely damaged and the dilator shaft was separated.The separated section was off the mandrel.Although it is unknown what angle the introducer entered the patient, the damage found is consistent with the introducer not entering at the intended 45 degree stick in a heavily calcified lesion.
Event or Problem Description
Received sus voluntary event report mw5075387 form, 21mar18.Md inserted needle to get access.Md inserted guidewire.Md inserted sheath through guidewire.When he removed inner sheath, he noticed that the introducer was not intact.He then pulled back the wire and noticed that the remaining introducer was stuck to the wire.All components were successfully retrieved and accounted for.Diagnosis or reason for use: sick sinus syndrome.

• Brand Name: MICRO-INTRODUCER
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7441373
• Report Number: 2134812-2018-00027
• Device Sequence Number: 1252405
• Product Code: DYB
• UDI-Device Identifier: M2067267V0
• UDI-Public: M2067267V0
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

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: No Information
• Device Expiration Date: 12/04/2020
• Device Model Number: 7267V
• Device Lot Number: 617394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/18/2018
• Patient Sequence Number: 1