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

Model Number	7195V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A returned product evaluation was unable to be completed as no product was returned.Multiple attempts were made to obtain further information and device return for investigation; however, no response was received.Device history record was reviewed for this lot and no nonconformances were related to this event, therefore supporting the device met material, assembly and performance specifications.Root cause for this complaint cannot be confirmed.
Event or Problem Description
Copy of mdr and letter received october 30, 2018 from hospital site.Patient was to have heart cath.Access to right femoral artery.4f micro-puncture introducer inserted on wire, scalpel was used to widen insertion site, proximal half micropuncture sheath removed from wire noting distal portion of sheath remained in the femoral artery.We were unable to retrieve distal portion of sheath.Vascular surgery consulted and took patient to the or to retrieve sheath.Patient remained stable throughout the incident and patient admitted to hospital.

• Brand Name: MICRO-INTRODUCER
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8115188
• Report Number: 2134812-2018-00088
• Device Sequence Number: 1653272
• Product Code: DYB
• UDI-Device Identifier: M2067195V0
• UDI-Public: M2067195V0
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2018

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 Expiration Date: 07/31/2021
• Device Model Number: 7195V
• Device Lot Number: 630972
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR