MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC MI,4FST,40CM,NIT/TUN7ECO; INTRODUCER, CATHETER

Catalog Number	7266V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that " while removing micropuncture to deploy angioseal, tip of the dilator broke off.Retrieved by snare.Contents bagged and delivered to nsm.".Additional information received from customer on 25sept2024: "the patient did not experience any negative symptoms and the procedure was completed without further complication.The patient was discharged safely the same day.No emergency treatment was necessary.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).No return product evaluation could be completed as the device was not returned for investigation.The customer supplied picture was reviewed and the shaft of the sheath was observed to be separated.The polymer appears to be stretched at the separated junction.A dhr review was completed for lot 73k2300364.No issues or non-conformities were noted.Case details were reviewed.As per the additional information received, patient did not experience any symptoms.Piece was retrieved with a snare.Based on the product evaluation, the most likely root cause of the issue is operational context and/or unintended use error.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that " while removing micropuncture to deploy angioseal, tip of the dilator broke off.Retrieved by snare.Contents bagged and delivered to nsm.".Additional information received from customer on (b)(6) 2024: "the patient did not experience any negative symptoms and the procedure was completed without further complication.The patient was discharged safely the same day.No emergency treatment was necessary.".

• Brand Name: MI,4FST,40CM,NIT/TUN7ECO
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20382054
• Report Number: 2134812-2024-00052
• Device Sequence Number: 18159096
• Product Code: DYB
• UDI-Device Identifier: 10841156107086
• UDI-Public: (01)10841156107086(11)231211(17)261012(10)73K2300364(21)
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: Health Professional
• Device Catalogue Number: 7266V
• Device Lot Number: 73K2300364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown