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

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2022

Event Type  malfunction  

Event 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.".

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).

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.

Manufacturer Narrative

This report is being submitted as follow up no.2.

• Brand Name: TERUMO GLIDECATH CATHETER
• Type of Device: 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
• MDR Text Key: 289614982
• Report Number: 9681834-2022-00026
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772534
• UDI-Public: 04987350772534
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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