MAUDE Adverse Event Report: PROGREAT CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number MC-PC2415

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.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 shipping inspection record of the involved product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that the involved progreat was used during the procedure.There was an unknown issue with the end of the micro guide.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update the device return date in section d9, update section h3, and to provide the completed investigation results.It was initially reported the actual device was available for evaluation; however, it was confirmed that the device was not available.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A picture of the actual sample was provided.Review of the picture revealed that the distal section had been cut at two points; however, the details of the cut shape could not be observed.Review of the manufacturing record of the involved product code/lot# combination confirmed that there was not any problem in the assembling process such as equipment failure.No anomaly was recorded in the results of the dimensional inspection and visual inspection, which were performed after the assembling process.Based on the past reproductive test result, it is known that the same product-type catheter may be cut at two points when it is inserted in a diagnostic catheter with a two-way stopcock and the two-way stopcock is turned.Ifu states: if any resistance is felt, do not remove the micro catheter system 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.If the guiding catheter is fitted with a stopcock, do not close the stopcock with the catheter inside the guiding catheter.The catheter may be broken.It is likely that the tip of the actual sample may have been trapped for some reason, and then an excessive tensile load was applied to the actual sample in that trapped state, leading to the cut of the catheter; while the actual sample was inserted in an involved device with a two-way stopcock, the two-way stopcock may have been manipulated.Due to this, the actual sample may have been pinched with resultant cut of the catheter.However, with no return of the actual device, 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
• MDR Report Key: 10183217
• MDR Text Key: 196075047
• Report Number: 9681834-2020-00113
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• 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-PC2415
• Device Lot Number: 191002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2019
• 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