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 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): (b)(4).The actual sample was received for evaluation.Visual inspection of the actual catheter and the guidewire samples revealed no anomaly such as a breakage in their 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, and something was clogging.In the remainder of the catheter, there was no anomaly including 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, and a black substance was deposited inside the buckled.The black substance was analyzed qualitatively by ft-ir and confirmed to have ir-spectra very similar to those of the urethane outer layer of the preloaded guidewire of this product.The inner and outer diameters of the catheter tube were measured on the area other than that buckled and confirmed to meet the factory's 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 430mm-780mm from the distal end of the device.Based on this and the qualitative analysis result, it was likely that the black substance deposited inside the buckled area of the actual catheter was the peeled-off urethane outer layer of the actual guidewire.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 in the distal direction, and some abrasions were observed near the peeled-off urethane.Based on this, it was 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 factory's 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 did not advanced any further.Reproductive testing was performed with a factory-retained progreat sample (guidewire-preloaded type), which was in an insufficient primed state.When the guide wire was pulled from the catheter quickly, resistance was perceived.Subsequently, when the guidewire in that state was pulled further, the catheter tube underneath the anti-kink protector near the bonded joint between the catheter and the hub became buckled.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.The abraded pieces of the urethane outer layer were deposited inside the buckling area of the catheter; when the guidewire was re-inserted into the catheter, it got caught by the buckling area of the catheter and could 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.Once the guide was completely out of the micro catheter, the doctor wanted to put it back in to navigate the artery, however, it was impossible to re-enter the guide into the catheter.The tip of the guidewire was blocked at the catheter hub.The patient was not harmed.The procedure outcome was not reported.

• Brand Name: PROGREAT CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, md ; 2837866718
• MDR Report Key: 10475724
• MDR Text Key: 214339940
• Report Number: 9681834-2020-00165
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: MC-PP27131
• Device Lot Number: 191211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2019
• 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