MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PROGREAT CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problems Break (1069); Stretched (1601); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/20/2023

Event Type  Injury  

Manufacturer Narrative

Patient identifier, age, date of birth, sex, weight, ethinicity & race: requested, not provided.Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k): k033913.The actual sample upon receipt was one progreat.Visual inspection of the actual sample found that the distal end had been fractured.Magnifying inspection of the actual sample found that the outer layer at the distal end had been torn.It had been waved and elongated from the distal end to approximately 205 millimeters (mm) from the distal end.The reinforcement coil had been elongated at approximately 15mm - 20mm from the distal end.The edge of inner layer was located at approximately 15mm from the distal end, and the outer layer had been crushed in the vicinity of its distal side.It had been crushed at approximately 80mm from the distal end.Electron microscopic inspection of the actual sample found that there were abrasions in the vicinity of fractured section.It was presumed that some hard object came into contact with the involved section.Comparison between the actual sample and the product with the involved product code found that the actual sample was an approximately 20mm longer than the product with the involved product code due to elongating.The actual sample had been crushed at approximately 80mm from the distal end of fractured section, and the outer diameter decreased sharply to the distal side starting from the crushed section and was fractured.In order to simulate the condition of actual sample described above, both at the distal end and at approximately 80mm from the distal end of the product with the involved product code were held, and elongated by applying pulling force in the distal direction until the outer diameter became equivalent to that of the actual sample.Since the product with the involved product code was approximately 5mm longer than the actual sample, it was presumed that the actual sample was missing at least 5 mm.The outer layer of actual sample was removed, and magnifying inspection of the inner layer was performed.The distal end of inner layer had been flared.It was presumed that some hard object came into contact with the involved section.Red substance had been adhered to the lumen of inner layer.Component analysis of red substance found in investigation of the actual sample was performed by ft-ir*.It was similar to the spectrum of casein (protein), and the involved substance was presumed to be a blood clot.Ft-ir (fourier transform infrared spectroscopy): an analysis method that irradiates substances with infrared light and measures the transmitted or reflected light for structural analysis and quantitative analysis.The outer diameter of the outer layer (normal section): it met the factory's specifications.No anomaly was found.The manufacturing record and the shipping inspection record of the product with the involved product code found no anomaly.The past complaint file of the product with the involved product code/lot number found no other similar report from other facilities.Investigation of the combined device found that the interlock-18, a combination coil, is a mechanical detachable coil in which the coil and delivery wire are connected by an arm (hook).Based on the investigation result, as a possible cause of this case, the following mechanism was inferred.With the distal end of actual sample in the state where force was applied with cranked shape, the combined coil was passed through while feeling resistance.As a result, the distal end of inner layer of the actual sample was flared.In addition, since the blood clot adhered to the lumen of actual sample or the surface of combined coil, the slid ability between the inner layer of actual sample and the combined coil decreased, and a frictional load was generated on the inner layer.Since the combined coil was pushed and pulled, the adhesion between the outer layer and the inner layer was lowered starting from the flaring of the distal end of inner layer of the actual sample, and the inner layer was damaged.When the delivery wire of combined coil was removed, the inner layer of actual sample and the reinforcement coil moved to the hand side.As a result, the distal end of actual sample became in a state of only the outer layer.The section that became only the outer layer on the actual sample was trapped by some factor (e.G., lesion).The actual sample was removed.As a result, the outer layer was torn and fractured.It was also inferred that the catheter crushed at approximately 15mm and 80mm from the distal end, which hindered passing through the combined coil.Regarding the occurrence of crush, it was inferred that compressive force was applied to the involved section.However, it was not possible to clarify when it occurred.Relevant instructions for use (ifu) reference: "do not manipulate the catheter by force.The catheter tip, highly flexible, may be stretched or damaged"."if any increase of resistance is felt when infusion, replace the catheter with a new one.Injection against increased resistance may cause the catheter to break, resulting in damage to the vessel."."if any resistance is felt, do not remove the catheter by force.Withdraw the catheter carefully together with the guiding catheter.Removing the catheter by force may result in the catheter breakage/separation, which may necessitate retrieval.".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 Description

The user facility reported that when the (b)(4) device involved was inserted into the angiographic catheter, an unusual resistance was felt during the procedure, therefore the use of it was stopped.This product was inserted into the blood vessel and used together with an interlock-18.When the coil was inserted, resistance was felt on the distal side of the catheter, however, it was manipulated carefully to place two coils.Since the blood vessel running at the next target position was steep, the distal end of angiographic catheter could not be inserted.Coil embolization was performed with only the distal side of this product inserted.Although there was no backup of the parent catheter and it was in an unstable state, the interlock-18 was inserted.The parent catheter moved every time the coil was inserted, and the distal end of product was in the state where force was applied with a cranked shape.When the coil passed through the catheter, resistance was still felt, however it was manipulated carefully to place some coils.After the coils were placed, the product was attempted to be pulled back into the angiographic catheter, and a very strong resistance (a sensation that only the catheter jacket part was elongated) was felt.Under x-ray fluoroscopy, it was confirmed that the tip marker of this product had returned into the angiographic catheter.Therefore, when the product was pulled out as it was, the distal side of product was in a state of elongating.When the pc2413 was taken out of the patient's body to see the condition of catheter, the catheter was kinked.The product was not used, and it was replaced with a new one to continue treatment.There was no surgical intervention required.Since the distal end of actual sample was found to be fractured, it was inferred that the fractured piece may remain in the patient's body.The procedure outcome was completed successfully.

• Brand Name: PROGREAT CATHETER
• 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 ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16599773
• MDR Text Key: 311858741
• Report Number: 9681834-2023-00056
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: MC-PC2413
• Device Lot Number: 220414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2022
• 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
• Treatment: 4FR ANGIOGRAPHIC CATHETER.; INTERLOCK-18.
• Patient Outcome(s): Other; Required Intervention