MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA TERUMO NAVICROSS SUPPORT CATHETER

Model Number	NC35151
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: the lot number was not provided only the di portion of the udi number is available.The actual device was not returned to the manufacturing facility for evaluation.Therefore, the investigation results are based on the user facility information and a retention sample from the reported product code.Visual inspection found no anomalies along the total length.Magnifying inspection did not reveal any anomalies which would be a trigger of dislodgement of the marker.The lumen was inspected at the distal end and at the hub under magnification and confirmed to be in the normal state with no generation of a deformity.Dimensional check of the outside and inside diameters verified the sample met manufacturing specifications.Simulation testing was conducted on a product sample.The sample was dented at approximately 40mm and 110mm from the distal end.The sample was then subjected to a tensile force, the shaft started to become thinner in diameter and the radiopaque markers dislodged from the shaft before the shaft became fractured.The product code and lot number was not provided by the user facility, which prevented a meaningful review of production and complaint records.There is no evidence that this event was related to a device defect or malfunction.The retention sample was confirmed to be normal product.Although the exact cause of the reported event cannot be definitively determined based on the simulation testing, the actual sample may have been subjected to an excessive pulling force resulting in the dislodgement of the marker.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.H3 other text : actual device not available.
Event or Problem Description
The user facility reported the marker came of the device during a procedure.Follow up communication with the user facility confirmed the following information: the distal marker of the navicross came off in the patient's sfa; it was retrieved with a snare; the procedure was completed; and the patient's condition was reported as good.

• Brand Name: TERUMO NAVICROSS SUPPORT CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6122536
• Report Number: 9681834-2016-00274
• Device Sequence Number: 162158
• Product Code: DQY
• UDI-Device Identifier: 04987350709226
• UDI-Public: 04987350709226
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2016

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 Model Number: NC35151
• Device Catalogue Number: WS*NA35153H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2016
• Initial Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other