MAUDE Adverse Event Report: INTERRAD MEDICAL SECURACATH; SUBCUTANEOUS ENGINEERED STABILIZATION DEVICE

Model Number	SCR-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On april 18th, 2019, interrad medical received a user facility report regarding a 7f securacath device occluding flow when placed on a bard 7f dl hickman catheter.Interrad medical reached out to the user facility and was able to have the device returned for evaluation.The evaluation included a review of internal documents, physical examination of the device and type of catheter involved.There were no concerns identified with the internal document review and there were no indications of any manufacturing defects or anomalies with the securacath device.The bard 7f dl hickman catheter was evaluated and found to have 2 significantly different catheter outer diameters (ods).The distal segment of the catheter was approximately 7f (2.3mm) od, but the proximal segment near the cuff was 10.2f (3.4mm) od.The correct size securacath device for the 7f hickman catheter proximal to the cuff would be a 10f securacath device.Per the securacath instructions for use, "select the appropriate size securacath device to match the catheter diameter.If catheter is labeled with half french size, use the closest smaller size securacath".This was not a malfunction of the securacath device and no injury was reported.This is being reported to provide a response to the user facility report of a securacath device malfunction (medwatch report #(b)(4)).The conclusion of interrad medical's evaluation is that there was not a malfunction of the device but the cause of the issue was the incorrect securacath size being selected due to the location where the securacath was being placed on the catheter.The bard 7f dl hickman has a larger od proximal to the cuff where the securacath would be placed then the labeled french size indicates.The package label for this catheter does indicate the different dimensions in millimeters for the larger and smaller ods in a diagram on the package label.
Event or Problem Description
After inserting a bard 7f dl hickman catheter a 7f securacath device was placed and noted the lines were occluded.The securacath device was removed without further incident and saved.

• Brand Name: SECURACATH
• Common Device Name: SUBCUTANEOUS ENGINEERED STABILIZATION DEVICE
• Manufacturer (Section D): INTERRAD MEDICAL; 181 cheshire lane; suite 100; plymouth MN 55441 5468
• MDR Report Key: 8724637
• Report Number: 3007795799-2019-00003
• Device Sequence Number: 13954056
• Product Code: OKC
• UDI-Device Identifier: 00865382000242
• UDI-Public: (01)00865382000242(17)201031(10)A1850
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K180769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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 Expiration Date: 10/31/2020
• Device Model Number: SCR-01
• Device Catalogue Number: 400120
• Device Lot Number: A1850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1