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

Model Number	7266V
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being based on the visual investigation and condition of the returned sample.A manufacturing record review was completed and zero nonconformances were found.The returned product evaluation confirmed the puncture/hole in the sheath.The sheath was kinked at the section where the hole was present.Based on the event details the most likely root cause for the failure is the mandrel punctured the sheath as the doctor was trying to advance the sheath.
Event or Problem Description
Dr.Was using mik for access in a varilase case.When he tried to advance the 035"" j-tip wire through the mik sheath, he felt resistance.Dr.Than removed the j-tip wire, and used the mik mandrel to advance and removed the mik sheath.The tip of the sheath showed a puncture at the distal tip.Mik sheath removed and placed in biohazard bag with packaging.No patient impact or injury reported.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7441273
• Report Number: 2134812-2018-00025
• Device Sequence Number: 1421851
• Product Code: DYB
• UDI-Device Identifier: M2067266V1
• UDI-Public: M2067266V1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2017

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: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: 7266V
• Device Lot Number: 594179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 04/18/2018
• Patient Sequence Number: 1