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

Model Number	N/A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Implanted date: device was not implanted.Occupation: registered nurse (rn).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.A review of the manufacturing record and the product-release judgement record of the involved product/lot number combination confirmed there was no anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.(b)(4).
Event or Problem Description
The user facility reported that the back end of the glidecath device involved broke off.There were no patient complications.The procedure was completed successfully.There was no patient injury/medical or surgical intervention required.
Event or Problem Description
Additional information was received on 11 apr 2022: there was no blood loss.The broken hub did not go inside of the patient, therefore there was no removal or surgical intervention required.The procedure was a peripheral angiogram.The procedure was not completed with the device.The incident happened in the middle of the case.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information to section b5, update section d9, section h3, and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.There was no anomaly confirmed in the relevant historical record.As a cause of the reported event, it was presumed that the actual sample was exposed to an excessive tensile load, which resulted in the fracture.Since no actual sample was returned for analysis, the definite cause of occurrence could not be determined.Ashitaka factory manufacturing process maintains the product quality by performing the following operation and inspections: i) in the tube molding process, the shaft was formed on the od-controlled core wire and then the core wire was removed so that the inner diameter of the shaft is assured; ii) before the packaging process, 100% visual inspection of the catheter is performed to assure that there is no anomaly including a crush; iii) in the packaging and cartoning processes, dedicated tools and containers are used for handling this product to protect the product and to prevent the occurrence of the crush.Please refer to the following warning indicated in the ifu (instructions for use) of this product: 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.".

• 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: 13937661
• Report Number: 9681834-2022-00052
• Device Sequence Number: 6505344
• Product Code: DQO
• UDI-Device Identifier: 04987350772213
• UDI-Public: 04987350772213
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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 Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CG416
• Device Lot Number: 210225
• 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: 03/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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 Age: 79 YR
• Patient Sex: Unknown