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

Model Number	7267V
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.Manufacturing record review was completed and no related nonconformances were found.If the device returns for evaluation a follow-up report will be submitted.Cause could not be established.
Event or Problem Description
It was reported that the tip of the wire broke off in a patient during a difficult access of the popliteal vein.Procedure aborted due to the inability to gain vein access with neither the vsi product nor the competitive product.Hemostats were used to try to pull out the wire tip.No further complications were reported.
Additional Manufacturer Narrative
No product was returned to vsi/teleflex for investigation.The account stated that resistance was met during advancement and withdrawal of the wire.It was also noted that the wire buckled many times during advancement, and it is unknown if there was a kink in the wire.The vessel was calcified and chronically occluded.Per ifu it states," never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the guidewire against resistance may result in separation of the guidewire tip, damage to the guidewire, or vessel perforation".The most likely cause of the issue is use related during access.The type of damage and/or length of the tip separated cannot be determined without product evaluation.
Event or Problem Description
Additional information received to clarify the vessel was calcified and chronically occluded.There was resistance experienced while using the wire during advancement and withdrawal.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHTER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10460323
• Report Number: 2134812-2020-00051
• Device Sequence Number: 3273912
• Product Code: DYB
• UDI-Device Identifier: 20841156102927
• UDI-Public: (01)20841156102927
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

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: 03/31/2023
• Device Model Number: 7267V
• Device Lot Number: 670810
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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: 62 YR
• Patient Weight: 104