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

Model Number 7266V

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2017

Event Type  malfunction  

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 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
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 7441273
• MDR Text Key: 106031123
• Report Number: 2134812-2018-00025
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: M2067266V1
• UDI-Public: M2067266V1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1