MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC VSI MI,4F,40CM,SS/SS,7CMSMT; INTRODUCER, CATHETER

Catalog Number	7246V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: patient undergoing left heart catheterization.When removing 4fr micro sheath, md noticed part of the sheath was missing.Md did not aggressively pull on sheath.He checked under fluoro and did not see the missing piece.He inserted a 6fr guide, interventional wire and balloon in an attempt to blindly snare the missing piece but was unsuccessful.Prior to pulling sheath, aspirated approx.20 ml blood and sheath pulled without pressure until removed from patient then immediate manual pressure for 15 mins to ensure successful hemostasis.Site remained soft, not hematoma and dry occlusive dressing applied.6fr sheath was flushed to see if broken piece of 4fr sheath was present.No evidence of broken 4 fr sheath.Md and patient updated after sheath pull.Patient denied any complaints, remains hemodynamically stable.Additional information: approx 5cm of the device separated in the right femoral artery.There was no issues on access.The vessel had no reported tortuosity or calcification.The separated device was not seen on floroscopy and there is no additional interventions planned.The patient is reported as fine with no reported harm or consequence.
Event or Problem Description
It was reported that: patient undergoing left heart catheterization.When removing 4fr micro sheath, md noticed part of the sheath was missing.Md did not aggressively pull on sheath.He checked under fluoro and did not see the missing piece.He inserted a 6fr guide, interventional wire and balloon in an attempt to blindly snare the missing piece but was unsuccessful.Prior to pulling sheath, aspirated approx.20 ml blood and sheath pulled without pressure until removed from patient then immediate manual pressure for 15 mins to ensure successful hemostasis.Site remained soft, not hematoma and dry occlusive dressing applied.6fr sheath was flushed to see if broken piece of 4fr sheath was present.No evidence of broken 4 fr sheath.Md and patient updated after sheath pull.Patient denied any complaints, remains hemodynamically stable.Additional information: approx 5cm of the device separated in the right femoral artery.There was no issues on access.The vessel had no reported tortuosity or calcification.The separated device was not seen on floroscopy and there is no additional interventions planned.The patient is reported as fine with no reported harm or consequence.
Additional Manufacturer Narrative
Qn# (b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.Unit was manufactured at tecate.A dhr review was completed.All processes were followed correctly.No deviations or non-conformances were noted.Case details were reviewed.Customer stated " 4 fr mik sheath was missing when removed from the patient during a left heart catheterization".No unit was returned to vsi/teleflex for evaluation.It is unknown what damages were incurred on the shaft that could have caused the separation.Per 106699 sub assembly drawing of the sheath, the shaft of the sheath measures 10.2 cm.Additional information was requested.A response was received.Approximately 5 cm of shaft was separated.No calcification or tortuosity was noted.Customer inserted a 6f guide, interventional wire, and balloon to blindly snare the missing piece but was unsuccessful.Approximately 20 ml of blood was aspirated, and the sheath was pulled out without any pressure.Manual pressure was held for 15 min and hemostasis was achieved.The guide sheath 6f was flushed to see if any broken piece of the mik sheath was noted.No other separation or pieces were noted.Patient was hemodynamically stable.It is unknown if the shaft of the sheath was subjected to any resistance.Per ifu states the following warning - 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.A manufacturing record review was completed by tecate and no related nonconformances were found.Based on the information, the most likely root cause of the issue is undeterminable.

• Brand Name: VSI MI,4F,40CM,SS/SS,7CMSMT
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17478091
• Report Number: 2134812-2023-00033
• Device Sequence Number: 2530973
• Product Code: DYB
• UDI-Device Identifier: 10841156103149
• UDI-Public: 10841156103149
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/11/2023

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: 08/11/2025
• Device Catalogue Number: 7246V
• Device Lot Number: 73H2200256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/07/2023
• 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 Age: 53 YR
• Patient Sex: Male