MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA TERUMO GLIDECATH CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received a user facility medwatch report #(b)(4).The event description states: "the user facility reported that the glidecath device involved was used for an endovascular intervention on the patient's aorta.When the device was pulled out, approximately 12 centimeters sheared off and was left inside the patient's aorta.The surgical team spent approximately 30 minutes removing the broken pieces and was able successfully removed them all.There were no significant complications, but the event could have been a catastrophe.The original intended procedures were an aortography, abdominal, by serialography with radiological supervision/interpretation and a thromboendarterectomy, patch graft in the common femoral artery." additional information was received on 08 apr 2022: there was no blood loss.
Additional Manufacturer Narrative
Implanted date: device was not implanted.Implanted date: device was not implanted.Occupation: clinical engineer.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.Since the lot number was unknown, history inspections could not be performed.Since the lot number was unknown, only the di no.Is listed.Please see mdr (b)(4) for the importer report on this reported event.(b)(4).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.Since the actual sample was not returned to ashitaka factory, therefore the investigation of it was unable to be performed.The results of the history inspectionares described in the preliminary report.As a cause of this complaint, it was inferred that the product was sheared off due to an applied excessive pulling force.The cause of occurrence could not be clarified since an evaulation was not conducted.Ashitaka factory assures the quality of this product by performing following inspections: i) after the shaft is molded on the core wire whose outer diameter is controlled, the core wire is removed to assure the inner diameter of shaft; ii) before the packaging processes, 100% magnifying inspection is performed to assure that there is no anomaly including a breakage on the catheter; iii) in the packaging and cartoning processes, dedicated tools and containers are used to protect the product and to prevent generation of a breakage.Ifu (instructions for use) of this product includes the following warning: "directions for use warning never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.Failure to exercise proper caution may result in damage to the vessel or catheter.Separation of the catheter may occur requiring retrieval in some cases.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the attached maude report.Terumo tmc performed a maude search on (b)(6) 2022.Report number (b)(4) was found and was confirmed to be of the same reported event, and therefore the maude report has been provided.

• Brand Name: TERUMO GLIDECATH CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: stephanie handy ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14189329
• Report Number: 9681834-2022-00068
• Device Sequence Number: 11882435
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K915414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2022

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: N/A
• Device Catalogue Number: CG415
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 04/26/2022; 04/27/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 04/26/2022; 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 37 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White