MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC MI,5F,40CMAT,7CMSMT; INTRODUCER, CATHETER

Catalog Number	7219V
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: this patient was in a mitral clip procedure.A pericardial effusion was noted after the mitral clips were released and pericardiocentesis was performed.During the pericardiocentesis, a micro introducer sheath was inserted, and the physician had a difficult time advancing the guidewire.After attempting to rewire the micro sheath, the micro introducer sheath broke, and the physician was unable to retrieve the sheath from the patient's body.Cvts (cardiovascular and thoracic surgery) was contacted, and the or (operating room) team arrived to cath lab to perform a small pericardial window to retrieve the sheath.The retained piece of sheath was retrieved successfully, and fragments were given to cath lab manager.
Event or Problem Description
It was reported that: this patient was in a mitral clip procedure.A pericardial effusion was noted after the mitral clips were released and pericardiocentesis was performed.During the pericardiocentesis, a micro introducer sheath was inserted, and the physician had a difficult time advancing the guidewire.After attempting to rewire the micro sheath, the micro introducer sheath broke, and the physician was unable to retrieve the sheath from the patient's body.Cvts (cardiovascular and thoracic surgery) was contacted, and the or (operating room) team arrived to cath lab to perform a small pericardial window to retrieve the sheath.The retained piece of sheath was retrieved successfully, and fragments were given to cath lab manager.
Additional Manufacturer Narrative
(b)(4).A product evaluation could not be completed as there was no product returned for evaluation.A dhr review was completed for lot 73m2200054, and no issues or nonconformities were noted.Case details were reviewed.It is unknown where exactly the sheath broke.The ifu states the following warning and precaution: 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.As per the reported information, physician experienced difficulty advancing the guidewire.This indicates potential anatomical issues or some concomitant device interaction.No details were provided by the customer to confirm the case.Surgery was employed by ctvs surgeon to remove the sheath.A manufacturing record review was completed and no related nonconformances were found.Based on the limited information, the most likely root cause of the issue is undeterminable.The der process will continue to monitor for any similar events.

• Brand Name: MI,5F,40CMAT,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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19268124
• Report Number: 2134812-2024-00019
• Device Sequence Number: 12601577
• Product Code: DYB
• UDI-Device Identifier: 10841156102739
• UDI-Public: 10841156102739
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (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): 04/09/2024

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: 12/08/2025
• Device Catalogue Number: 7219V
• Device Lot Number: 73M2200054
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/11/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 58 KG