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

Model Number	7195V
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformance's were found.A returned product evaluation was also completed and confirmed the complaint received.Two indents were found in the proximal shaft/distal hub of the sheath, consistent with tubing pinch during hub molding.The unit was flushed and found to leak, confirming the unit had holes in the side of the sheath where the indents were located.A non-conformance was initiated to further investigate the complaint received and document any applicable corrections.
Event or Problem Description
Micropuncture sheath was inserted into right arm fistula.Contrast was injected into micropuncture sheath.Contrast squirted out of hole in sheath, where the tube meets the hub.

• Brand Name: MICR-INTRODUCER
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8046873
• Report Number: 2134812-2018-00081
• Device Sequence Number: 19200818
• Product Code: DYB
• UDI-Device Identifier: M2067195V0
• UDI-Public: M2067195V0
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K1080913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2018

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: Health Professional
• Device Expiration Date: 05/08/2021
• Device Model Number: 7195V
• Device Lot Number: 625935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR