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

Catalog Number MC-PP27131

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k033913.The actual catheter sample and the guidewire sample were received for evaluation.Visual inspection revealed no anomaly such as a break in the visible range.Inspection of the actual catheter sample: magnifying inspection confirmed there was not any anomaly including a kink or flattening in the shaft.X-ray fluoroscopic inspection revealed that the coil pitch inside the anti-kink protector was uneven.No other anomaly was noted in the remainder of the catheter, such as an obstruction.The anti-kink protector was removed and the area underneath it was inspected visually.The catheter tube had been buckled near the bonded joint between the hub and the catheter.The inner and outer diameters of the catheter tube were measured on the area other than that buckled and confirmed to meet the manufacturer control criteria.Inspection of the actual guidewire sample: visual and magnifying inspections found that the urethane outer layer had been peeled-off.This was observed approximately 900mm-1060mm from the distal end of the device.No kink or no other anomaly was observed in the remainder of the guidewire.Electron microscopic inspection of the area where the urethane outer layer had been peeled off revealed that a part of the urethane had been turned up toward in the distal direction.In addition, some abrasions extended toward the distal direction were observed on the surface near the area.Based on this, it is likely that the actual guidewire sample was exposed to an excessive abrading load while being pulled in the proximal direction.The outer diameter of the shaft was measured on the intact area and confirmed to meet the manufacturer control criteria.Electron microscopic inspection of the intact area near the peeled-off urethane outer layer confirmed the presence of cracked pattern peculiar to the hydrophilic coating of this product.From this, it was likely that the actual sample had no anomaly in the application state of the hydrophilic coating (the hydrophilic coating gets swollen when it contains moisture.In the dry state, cracked pattern appears on the surface.The cracked pattern has some inter-individual deference by product).An attempt was made to insert the actual guidewire sample into the actual catheter sample from the hub.As a result, the guidewire was stuck at the catheter's buckling area and not advanced any further.Reproductive test was performed with a factory-retained progreat sample (guidewire-preloaded type), which was in an insufficient primed state.When removing the guide wire from the catheter quickly, resistance was perceived.Subsequently, when pulling further the guidewire in that state, the catheter tube underneath the anti-kink protector near the bonded joint between the catheter and the hub became buckled, and the urethane outer layer of the guidewire was peeled-off and turned up in the distal direction due to having been abraded by the buckled section of the catheter.A review of the device history record and shipping inspection record of the involved product code/lot# combination was conducted with no findings.Ifu states: prime the catheter and guide wire sufficiently.Manipulation of an insufficiently primed catheter may cause wrinkling, separation of the catheter, and/or abrasion of the hydrophilic coating on the guide wire.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 when the pre-loaded guidewire was pulled out from the catheter, the friction resistance between the inner surface of the catheter and the outer surface of the guide wire increased due to insufficient priming, pulling the guidewire in that state caused the catheter tube underneath the anti-kink protector near the bonded joint between the hub and the catheter to become buckled; the surface of the guidewire was abraded by the buckling area of the catheter, resulting in the guidewire's urethane outer layer to peel off; when the guidewire was re-inserted into the catheter, it was caught by the buckling area of the catheter and not be advanced any further.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

This report has been deemed reportable based upon the evaluation of the actual device.The user facility reported that the involved progreat was used during the procedure.The catheter and gw could not pass.It did not instill, nor the guide enters the microcatheter.The procedure was completed successfully.The patient was not harmed.Additional information was received on "10ju2020".The time to reopen a new device was the amount of time the procedure was delayed.A new progreat was opened and used.The patient was treated using a new progreat.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide a correction.Initially the incorrect method code was inadvertently reported in section h6.Method code: 4103 was selected; however, the correct method code is: 4102.Therefore, section h6 has been updated to reflect the correct code.

• 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: 10458638
• MDR Text Key: 206165071
• Report Number: 9681834-2020-00164
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: MC-PP27131
• Device Lot Number: 191023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1