MAUDE Adverse Event Report: TOGO MEDIKIT CO.LTD. SUPERCATH 5; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number SP208-01

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/14/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturing records for the production lot of the device were reviewed and no abnormalities were found.The device involved in the event was not returned.Only the photos of the fractured device (without the catheter tube) were provided.The photos were examined and judging from this review a possible cause of this fracture is that repeated bending of the catheter base occurred during the indwelling because of insufficient fixation of the device to the patient's body.This resulted in a decrease in tensile strength of the catheter base to a point where the catheter could not withstand the pull force during removal from the patient's body and fractured.

Event Description

On (b)(6) 2017 at the (b)(6) hospital in (b)(6) it was reported that supercath5 safety i.V.Catheter was fractured at the catheter base when being pulled out of the patient's body during a procedure.The fractured portion was not detected on x-rays at the time but was later discovered with ct scan and surgically removed thereafter.There was no reported patient injury as a result of this event.

• Brand Name: SUPERCATH 5
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TOGO MEDIKIT CO.LTD.; 17148-6 aza kamekawa; oaza hichiya; hyuga city, miyazaki prefecture 883-0 062; JA 883-0062
• Manufacturer (Section G): TOGO MEDIKIT CO.LTD.; 17148-6 aza kamekawa; oaza hichiya; hyuga city, miyazaki prefecture 883-0 062; JA 883-0062
• Manufacturer Contact: yashaswini patwardhan ; 747 n. milwaukee ave; suite 102; libertyville, IL 60048
• MDR Report Key: 6635045
• MDR Text Key: 77379068
• Report Number: 9612126-2017-00004
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K140419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: SP208-01
• Device Lot Number: 16J08A8
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR