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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.1.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number confirmed that there was not any anomaly in them.2.A search of the complaint file found no other similar report of the product with the involved product code/lot number.3.Udi no.: (b)(4).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.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that the catheter broke inside the patient and distal end had to be retrieved with a snare.Looks like catheter was sheared due to the biopsy device.The patient was stable and there was no issue post operation.The patient has history of liver cancer.Procedure being performed was a trans jugular liver biopsy.There was no estimated blood loss.
Additional Manufacturer Narrative
The actual device has been returned for evaluation.Visual inspection of the actual sample (unaided eye, microscope, and electron microscope).The fracture was located near the distal end.The shaft had been fractured diagonally.The fractured edges of the distal and proximal portions matched in shape with each other, suggesting that there was no missing portion.There were scratches at the extension of fractures of both portions.Dimensions of the actual sample: the inner and outer diameters at the undamaged part were confirmed to meet the factory's specifications.No anomaly was observed.(cause of occurrence): no anomaly was found in the manufacturing history and product dimensions.Based on the situation at the time of occurrence and the condition of the actual sample, one possibility was that the catheter was scratched due to having been exposed to the biopsy device and fractured starting from this scratch when exposed to pulling force during subsequent manipulation.(countermeasure): ashitaka factory assures the quality of this product by performing following work and controls.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.Before the packaging, 100% magnifying inspection is performed to confirm that there is no anomaly such as a kink or a tear on the catheter.In the packaging and cartoning processes, dedicated tools and containers are used for handling this product to protect the product and to prevent a kink or a tear.The ifu of this product provides the following information.[instruction for use] the radifocus glidecath should be used by a physician who is well trained in manipulation and observation under fluoroscopy.[direction 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.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Additional Manufacturer Narrative
This report is being sent as follow-up no.2 to correct section d3.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, MD 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17804928
• Report Number: 9681834-2023-00195
• Device Sequence Number: 6727674
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2023

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 Expiration Date: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: CG415
• Device Lot Number: 230206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 09/15/2023; 12/15/2024
• Initial Report FDA Received Date: 09/23/2023
• Supplement Report FDA Received Date: 10/13/2023; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White