MAUDE Adverse Event Report: NUMED, INC. D'VILL INTRODUCER

Model Number	700
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to numed by the distributor / end user - back end of the dilator had broken off.Upon removal from the body they found that the distal tip of the dilator was no longer attached to the main body of the dilator.The distal tip of the dilator was sitting in the l main pulmonary artery still on the wire.They spent several hours trying to get it out unsuccessfully.The snare used, cut through the dilator tip and broke it into two more pieces.They ended up having to trap one piece under a stent in the iliac and the other embolized into a small subsegmental pulmonary artery branch, which they evaluated by ct and felt was higher risk to remove than to leave in place on anticoagulation.
Additional Manufacturer Narrative
A review of the device history record was performed and no issues were noted.There have no other complaints of this nature received on this product device lot.A review was also performed on the dilator component used in this lot of devices.There have been no other complaints of this nature for this component lot of dilators.The introducer was returned to numed on 8/4/2023.The dilator's hub is detached and the distal end of the dilator is also detached.Both breaks are clean with no stretching evident.The dilator was slowly bent until failure.The dilator broke instead of kinking (refer to break pic).A comparative d'vill was tested.The dilator was slowly bent until failure.After reaching a radius of under 1 inch, the dilator kinked without fracturing (refer to comparative pic).A pull test was performed on the junction between the dilator shaft and the luer hub.The junction failed at 23.059 lbf (102.61n), which is well above the 15n acceptance criteria outlined in the in vitro bench testing.The shaft stretched before failure (refer to comparative pull test pic).Testing showed that the complaint dilator had become brittle.This is consistent with extended exposure to uv light.The ifu has a statement that reads - "avoid extended exposure to light." the comparative device performed normally during the kink and pull testing.

• Brand Name: D'VILL INTRODUCER
• Common Device Name: INTRODUCER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12967
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 17603667
• Report Number: 1318694-2023-00007
• Device Sequence Number: 17718953
• Product Code: DYB
• UDI-Device Identifier: 04046955128297
• UDI-Public: 04046955128297
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2023

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: 08/31/2024
• Device Model Number: 700
• Device Catalogue Number: DV1485
• Device Lot Number: DV-0214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown