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

Model Number	7267V
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	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device kit was returned for evaluation.A manufacturing record review was completed and no related nonconformances were found., therefore supporting the device met material, assembly and performance specifications.The outer coil of the wire was unraveled.The weld joint that secures the outer coil to the core wire was not present.Based on the event details stating that the wire was withdrawn while still in the needle, it likely became caught on the point causing the separation of the tip.The ifu warns; "do not withdraw guidewires through metal needles; guidewires may shear or unravel.".
Event or Problem Description
Wire was sheared off by micro puncture needle.Medwatch received from site 12sep19.Uf/importer report # (b)(4).Additional information received 18sep19: per md, micropuncture wire through the micropuncture needle, but the wire would not advance much beyond the site of the needle puncture.Md decided to pull wire back through the micropuncture needle out of the body along with the needle.However, the wire would not come out back into the needle.Md decided to take out the wire and needle together as one assembly and while pulling both of them out, felt resistance, and a break in the wire.Needle and wire came out but could see tip of wire sheared and fractured and tip of wire missing.Fluoroscopy found piece of tip retained in subclavian vein.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9163448
• Report Number: 2134812-2019-00066
• Device Sequence Number: 13945987
• Product Code: DYB
• UDI-Device Identifier: 10841156102920
• UDI-Public: (01)10841156102920
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• 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): 09/12/2019

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: 04/30/2022
• Device Model Number: 7267V
• Device Catalogue Number: 7267V
• Device Lot Number: 650441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 57