MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS INTRODUCER; INTRODUCER, CATHETER

Catalog Number RR-F90K10S

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k062858, k082644.The actual sample was received for evaluation.Visual inspection of the actual mini guide wire sample revealed that the urethane coating had been separated from the core wire on approximately 0-100mm and 110mm-160mm from the distal end.The length from the proximal end of the actual sample to the distal end of the core wire was confirmed to be 450mm.From this, it was likely that the core wire was intact with no missing part in it.Magnifying inspection of the section where the urethane coating had been separated from the core wire (0-100mm from the distal end) revealed: the surface of the separated urethane coating was smooth like having been sheared off with an edged tool; the distal end of the separated urethane coating appeared to have been pulled and torn off; the distal end of the core wire showed the same cut end as that of the core wire cut in the specified length in the manufacturing process of this product.Magnifying inspection of the section where the urethane coating had been sheared off (110mm-160mm from the distal end) revealed that the shear surface of the urethane coating was smooth like having been sheared with an edged tool.Reproductive testing was performed on a current product sample and a factory-retained metal needle.Once the mini guide wire was inserted in the metal needle, the mini guide wire was withdrawn from the metal needle in a manner that the guide wire's urethane coating came into contact with the edge of the needle.As a result, the urethane coating was sheared off the core wire semi-circumferentially with exposure of the core wire.Magnifying inspection of the sheared urethane coating revealed that the sheared surface was smooth, and the distal end seemed to have been torn off.The state of the shearing of the urethane coating observed on the test sample was found similar to that observed on the actual sample.A review of the device history record and the shipping inspection record of the product code/lot# combination was conducted with no findings.Ifu states: do not use a metal cannula as an entry needle.Withdrawing the mini guide wire through a metal cannula or advancing a metal cannula over the mini guide wire may result in shearing of the mini guide wire or scraping of its plastic coating.This may lead to damage to the blood vessel or the sheath, as well as release of fragments from the wire into the blood stream.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that actual mini guide wire sample came into contact with the edge of the concurrently used metal needle when inserted in it.Subsequently, when the actual mini guide wire in that state was withdrawn from the metal needle, the urethane coating was sheared off the core wire.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the actual radifocus introducer was used for the insertion of ganz by anesthesiologist during cv operation.For the introduction of the sheath, the mini guide wire was used in combination with a metal needle.As a result, some sheared pieces of urethane coating remained in the vessel.The cardiologist and radiologist attempted to collect the sheared pieces with a snare or other devices; however, failed.The sheared urethane pieces still remain in the pulmonary vein.The patient was not harmed.The procedure outcome was not reported.

• Brand Name: RADIFOCUS INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, md ; 2837866718
• MDR Report Key: 9942475
• MDR Text Key: 196575292
• Report Number: 9681834-2020-00049
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2020

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 Expiration Date: 02/28/2022
• Device Catalogue Number: RR-F90K10S
• Device Lot Number: 190927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2019
• 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): Other; Required Intervention