MAUDE Adverse Event Report: INTERRAD MEDICAL SECURACATH

Model Number	400110
Medical Device Problem Codes	Device Issue (2379); Material Integrity Problem (2978); Physical Property Issue (3008); Torn Material (3024)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The picc was accessing an axilla vein (approximately 10mm deep) in the left arm near the arm pit.The hospital has theorized that a combination of dressing technique and atypical positioning may have contributed to the 'foot' separating, and the dislocation of the picc.The patient did not have other available access points.The hospital is not attributing the tip migration to the securacath.Evaluation of the securacath involved in addition to the testing performed by interrad on the returned securacaths, confirmed that the securacath experienced an unusual torsion load that most likely caused the nitinol 'foot' to separate from the securacath.Since first human use in 2010, no other 'foot' separation has been confirmed for securacath.Multiple attempts were made to submit the mdr prior to the due date, the report was delayed due to it issues associated with the esg website.
Event or Problem Description
(b)(6) 2017: (b)(4) distributor medical specialties (b)(4) was notified by a clinical nurse consultant of an incident involving securacath.A securacath had been placed with a picc on (b)(6) 2017.On (b)(6) 2017, it was observed that the securacath had come out while still attached to the picc which had migrated 5cm.On inspection by the picc team, they observed the nitinol "foot" on one side of the securacath had separated from the rest of the securacath and was still under the skin, the "foot" could be felt just beneath the skin, and was causing the patient no discomfort.The size of the "foot" is.194 inches (4.9 mm).On (b)(6) 2017, the patient returned to the hospital so that a new picc line could be inserted, which went well.The site where the "foot" of the securacath has separated was assessed and had healed without problem.It was decided to not attempt removal at this time as the patient was starting a chemotherapy cycle the same day.The foot of the securacath was causing the patient no discomfort.The picc team was of the opinion that complete removal would not be difficult should the patient want to proceed.

• Brand Name: SECURACATH
• Common Device Name: SECURACATH
• Manufacturer (Section D): INTERRAD MEDICAL; 181 cheshire lane; suite 100; plymouth MN 55441
• MDR Report Key: 6754559
• Report Number: 3007795799-2017-00014
• Device Sequence Number: 2014060
• Product Code: KMK
• UDI-Device Identifier: 00865382000228
• UDI-Public: (01)00865382000228(17)180930(10)A1623
• Combination Product (Y/N): N
• PMA/510(K) Number: K120935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/20/2017

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: Nurse
• Device Expiration Date: 09/30/2018
• Device Model Number: 400110
• Device Catalogue Number: 400110
• Device Lot Number: A1623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 07/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1