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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical received a user facility medwatch report # (b)(4).The event description states: "staff reported the terumo catheter "ruptured" during injection in a diagnostic cerebral angiogram procedure.No injury was identified related to the event.The catheter remains intact during the injection process.Preexisting characteristics that may have contributed to the event: hypertension.".
Additional Manufacturer Narrative
Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.Implanted date: device was not implanted.Occupation: master of science in nursing, registered nurse (msn, rn).Device manufacture date: unknown due to unknown lot number.Since the actual sample was not returned to ashitaka factory, the investigation of it was unable to be performed.Review of the manufacturing record and the shipping inspection record could not be performed since the involved lot number was unknown.Ifu of this product includes the following warning."before starting infusion, verify that the catheter has not been kinked or blocked.Failure to abide by this warning may cause the catheter to break/rupture/separate, resulting in damage to the vessel." regarding this case, it was inferred that the actual product was ruptured due to excessive pressure applied for some reason.However, since the actual product could not be investigated, and the record inspections could not be performed due to the unknown lot number, the cause of occurrence could not be identified.(b)(4).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide correction to section b4.The b4 date was inadvertently entered as 03/02/2022 instead of 03/03/2022.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2.

• 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: 13659118
• Report Number: 9681834-2022-00026
• Device Sequence Number: 1943500
• Product Code: DQO
• UDI-Device Identifier: 04987350772534
• UDI-Public: 04987350772534
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CG511
• Device Lot Number: YA25110A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 03/03/2022; 03/29/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/03/2022; 03/29/2022
• 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
• Patient Sex: Unknown