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

Model Number N/A

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: cath lab manager.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.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number combination confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that the procedure performed was a paravalvular aortic leak.The physician attempted to canulate the leak with the glide catheter involved.It was noted during the procedure the glide catheter felt snug/tight inside the leak.The physician attempted to remove the glide catheter and had to pull with more force than usual.It was noted the tip had broken off and was left in the leak.A snare was inserted and removed the broken tip safely.No harm to the patient and the procedure was able to be completed.The patient was in stable condition.The paravalvular plug procedure was completed successfully.There was no patient injury or surgical intervention required.Additional information was received on 21 mar 2023: an angiography was used to determine that the entire broken tip was safely removed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual device was returned.Actual samples upon receipt were the main body of the catheter and a fragment.Visual inspection of the actual samples found the length of the main body to be approximately 1065 millimeters (mm).Length of the fragment was approximately 155 mm.Total length was approximately 1220 mm.From this, it was thought that there was no portion missing from the actual samples in comparison with a current product.Magnifying inspection of the actual sample found that a compressed mark was observed near the distal end of fragment.The fracture of the fragment seemed to have been torn off.At the fracture of main body, the outer layer had been stretched and seemed to have been torn off.Reinforcement was exposed at the fracture of the main body.The outer layer at the fracture of both portions were similar in shape partially.Based on these results, and the similar shape of the fractured outer layer, it was considered that there was no portion missing from the actual samples.No anomaly in appearance such as a compressed mark or a scratch in other parts.At the fracture of the fragment, no exposure of reinforcement was observed.Electron microscopic inspection of the actual sample found the fragment had creases and traces of possible contact with some hard object in the compressed part near the distal end.From this, it was inferred the possibility that the actual sample came into contact with some hard object and caught on it.X-ray fluoroscopic inspection of the actual samples found the fracture had occurred at the distal end of reinforcement.The dimensions obtained the following results.The outer diameter of the undamaged part was within our control standard.No anomaly was observed.The inner diameter of the undamaged part was within our control standard.No anomaly was observed.Considering the possibility that the distal end of the actuals sample came into contact with a hard object, caught on it, and exposed to pulling force, leading to the fracture, the following simulation test was conducted.A factory-retained 4fr glidecath was combined with a 0.035" guidewire, the distal end was fixed, and then a pulling force was applied.Magnifying inspection of the condition of simulation sample found that it was fractured at approximately 155mm from the distal end.The area near the distal end where it had been fixed was compressed.The outer layer at the fracture of both portions was stretched and in a torn-off shape.At the fracture of the main body, reinforcement was exposed.At the fracture of the fragment, reinforcement was not exposed.From this, it was thought that the fracture occurred at the distal end of reinforcement.The state of simulation sample, with the compressed mark near the distal end and the fracture having occurred at the distal end of reinforcement, was similar to the state the actual sample.It was considered that the difference in the state of fracture surface observed, such as elongation, was due to the difference in the level of tensile force applied and the operation method.Based on the condition of the actual sample and description of the event, the following mechanism of occurrence was estimated.The part of the actual sample near the distal end might have come into strong contact with the lesion and caught on it.In order to release the caught state, strong pulling force was applied.As a result, the inner and outer layers were torn off at the distal end of the reinforcement, which is the part where the physical property of the catheter tube changes, leading to the fracture.Besides, the total length of the main body and the fragment were compared with that of a current product and concluded that there was no portion missing from the actual sample.Ashitaka factory manufacturing process assures the quality of this product by performing following inspections.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 scratch or crush on the catheter.In the packaging and cartoning processes, dedicated tools and containers are used for handling this product to protect it and to prevent it from crushing.The instructions for use (ifu) of this product includes the following information: "[directions for use] 5 /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: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• 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: 16673382
• MDR Text Key: 312606187
• Report Number: 9681834-2023-00074
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772237
• UDI-Public: 04987350772237
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CG417
• Device Lot Number: 220315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 04/10/2023
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White