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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted the actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code 11 has been referenced in the conclusions section of h6.A review of the device history records and the shipping inspection record of the involved product/lot# combination was conducted with no findings.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.- attachment: [fda mw5077489.Pdf].
Event or Problem Description
Per medwatch 5077489 received: the navicross support catheter's first gold marker came off the catheter and lodged in a terminal branch of the right lower kidney of the patient.The patient started to move and this is when the gold marker came off.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in.
Event or Problem Description
Additional information was received june 25, 2018.The gold marker was not removed from the patient.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the device return date and to provide the completed investigation.The actual sample was received for evaluation.Visual inspection revealed that the actual sample did not have the radiopaque marker which should be attached at approximately 42mm from the distal end of this product.Magnifying and electron microscopic inspections revealed that the outer surface had become rough on approximately 20- 42mm from the distal end of the device.This segment (on approximately 20- 42mm from the distal end of the device) was noted to have been flexed and slightly crushed.There was not any anomaly which would be a trigger of dislodgment of the radiopaque marker on the radiopaque marker attached at approximately 103mm from the distal end of the device and the segment around it.Magnifying inspection of the lumen at the distal end of the device found that the shaft had been slightly flattened.Total length and the inside and outside diameters on the undamaged segment were confirmed to meet the specifications.Ifu states: carefully handle the product under fluoroscopy.If any resistance is felt while handling the product, immediately stop the manipulation and find out cause of the resistance in order to avoid damage to blood vessels and separation or breakage of the product.There is no evidence that this event was related to a device defect or malfunction.It is likely that the distal radiopaque marker got loosened after having been crushed and deformed by some factor(s).Subsequently loosened radiopaque marker was caught in an object, including a lesion, and dislodged from the shaft.As a cause of the damage on the catheter shaft, it is likely that the accrual sample was subjected to some external force, including compressive force, bending force and abrading force, which exceeded the strength limit of this product.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: TERUMO NAVICROSS SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7614768
• Report Number: 9681834-2018-00114
• Device Sequence Number: 2221726
• Product Code: DQY
• UDI-Device Identifier: 04987350709264
• UDI-Public: 04987350709264
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K110540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2018

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: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: NC35900
• Device Lot Number: 170711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 07/20/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/19/2018; 08/03/2018
• 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
• Patient Age: 72 YR
• Patient Weight: 103