MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC MI,4F,40CM,NIT/TUN7CMECO; INTRODUCER, CATHETER

Catalog Number	7280V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn # (b)(4).
Event or Problem Description
It was reported that "issue with the transition dilator from one of teleflex's micro puncture kits.During the procedure, the outer catheter of the transition dilator disconnected from the hub and became a foreign body inside the patient." additional information: procedure was placement of a non-tunneled central line; access site was rij.The patient did have to have an additional procedure for retrieval, which happened immediately on the table and consisted of an additional access site at the right femoral vein.The device was successfully removed.The patient did well after the procedure without any complications.No injuries occurred from this incident.The patient did not experience and signs/symptoms due to this event.
Additional Manufacturer Narrative
(b)(4).One-unit of mik (lot 73f2300327) was returned to teleflex for evaluation.Blood particulates were noted on the unit.Unit was decont aminated and inspected.Hub separation was confirmed.Proximal end of the sheath was observed to have minor damages.The separation of sheath was observed to be clean.No sheath material noted within the hub.A dhr review was conducted for lot 73f2300327.No issues or nonconformities were noted.Based on product evaluation, the issue is likely due to manufacturing.Case details were reviewed.Customer stated ," issue with the transition dilator from one of teleflex's micro puncture kits.During the procedure, the outer catheter of the transition dilator disconnected from the hub and became a foreign body inside the patient".One unit of mik was returned for evaluation.Hub separation was confirmed.As per the additional information received, the access site was not heavily calcified or tortuous.Additional procedure was performed to retrieve the separated sheath.No injuries noted to the patient.Based on the product evaluation, the most likely root cause of the issue is related to manufacturing/process deficiency.Further investigation has been initiated under teleflex's quality system for this issue.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that "issue with the transition dilator from one of teleflex's micro puncture kits.During the procedure, the outer catheter of the transition dilator disconnected from the hub and became a foreign body inside the patient." additional information: procedure was placement of a non-tunneled central line; access site was rij.The patient did have to have an additional procedure for retrieval, which happened immediately on the table and consisted of an additional access site at the right femoral vein.The device was successfully removed.The patient did well after the procedure without any complications.No injuries occurred from this incident.The patient did not experience and signs/symptoms due to this event.

• Brand Name: MI,4F,40CM,NIT/TUN7CMECO
• 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: 18563000
• Report Number: 2134812-2024-00002
• Device Sequence Number: 17807445
• Product Code: DYB
• UDI-Device Identifier: 10841156103019
• UDI-Public: 10841156103019
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023

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 Expiration Date: 06/19/2026
• Device Catalogue Number: 7280V
• Device Lot Number: 73F2300327
• 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: 12/29/2023
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 68 KG