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

Model Number N/A

Device Problems Material Separation (1562); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.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 device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that after successfully coiling the accessory renal, he advanced the bmw wire (abbott) through the sos omni 2 catheter and tried to advance the progreat over the wire.They removed the progreat to flush it, and a bubble appeared at the distal end and it had come apart.The remaining part of the progreat was still on the wire and removed from the patient.A new progreat was used and the procedure was successfully completed.The patient was unharmed.Additional information was received on 03dec2019.It separated on the wire; however, both pieces came out without effort.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.The actual device was received for evaluation.Visual inspection revealed that the distal section had been swelled and elongated.The shaft had been crushed on approximately 230mm and 120mm from the distal end.Magnifying inspection found that section distal to the distal marker had been elongated by approximately 18mm; and did not find any anomaly such as a flaw or crash that could lead to leakage.Magnifying inspection found that the distal end of the actual sample had a trace of the shaft had been torn off.From this, it is conceivable that the actual sample was subjected to pulling force, elongated, and torn off.Brown substance was observed inside the actual sample.Magnifying inspection of the distal section found that brown substance was remaining inside the actual sample.The brown substance was subjected to qualitative analysis by sem-edx and confirmed to be high in sodium chloride and iodine.From this, the brown substance was presumed to be a mixture of physiological saline solution and contrast media.The brown substance was subjected to qualitative analysis by ft-ir and confirmed to have spectra very similar to that of protein (casein).From this, the brown substance was presumed to contain blood in addition to saline solution and contrast media.X-ray fluoroscopic inspection of the distal section revealed that the stainless-steel reinforcement had been partially crowded.From this, it was conceivable that the stainless-steel reinforcement was pushed in the distal direction when the actual sample was pulled in the proximal direction.X-ray fluoroscopic inspection of the distal section revealed that the outer layer only had been elongated and the inner layer was not elongated.From this, it is presumed that the outer layer was subjected to pulling force when the outer layer only was in a trapped state due to some factor.Magnifying inspection of the elongation on the outer layer revealed that the distal 50mm of the outer layer had been elongated.Magnifying inspection of the crushed sections did not find any anomaly such as a flaw that could lead to the generation of the crushes.The actual sample was leak-tested by being connected to a factory-retained syringe and injected with saline solution.A leak was observed from the elongated section on the outer layer.Magnifying inspection of the leaked point on the outer layer found a pinhole.The pinhole on the outer layer was inspected under sem and revealed to be a rupture developed from the inside toward the outside.From this, it was presumed that the pinhole occurred when pressure was applied to the outer layer from the inside.The outside and inside diameters of the shaft were measured on the intact section and confirmed to meet manufacturer specifications.The outer layer on the distal section was removed to inspect the inner layer.The surface of the inner layer on the distal section was found rough.The rough surface was located underneath the crowded stainless-steel reinforcement.From this, it was presumed that the stainless-steel reinforcement, when pushed forward, came into contact with the outer surface of the inner layer causing damage on the inner layer surface.The rough surface on the inner layer was inspected under sem.A pinhole was found at approximately 35mm from the distal end of the inner layer.The pinhole on the inner layer was inspected under x-ray ct and confirmed to have been rupture from the inside toward the outside.From this, it was presumed that the pinhole was caused when pressure was applied to the inner layer from the inside of the actual sample.Ifu states: when advancing the catheter into the peripheral vessel, draw it back slightly under fluoroscopy each time it has been advanced, to make sure that the catheter has not been advanced so far that it cannot be drawn back.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the distal end of the actual sample combined with the concurrently used guide wire was caught by some factor, and then subjected to pulling force.As a result, the shaft got elongated and fractured.Due to the elongated section, the guide wire and the inner layer of the actual sample became stuck to each other.When the guide wire in that state was attempted to be withdrawn, the stainless-steel reinforcement was pushed forward.Due to this, the outer surface of the inner layer was damaged.When the actual sample in that state was flushed, the damaged point on the inner layer could not withstand the pressure and got ruptured, resulting in the generation of the pinhole.Due to this pinhole on the inner layer, saline solution and contrast media flowed into the outer layer, resulting in the swelling of the outer layer and the generation of the pinhole on the outer layer.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: PROGREAT CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9503174
• MDR Text Key: 195435884
• Report Number: 9681834-2019-00215
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350771773
• UDI-Public: 04987350771773
• Combination Product (y/n): N
• PMA/PMN Number: K033913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: MC*PB2813Y
• Device Lot Number: 190522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/24/2019
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BWM UNIVERSAL II WIRE 300CM (ABBOTT); SOS OMNI 2 CATHETER
• Patient Age: 81 YR
• Patient Weight: 105