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

Model Number N/A

Device Problems Peeled/Delaminated (1454); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2023

Event Type  malfunction  

Event Description

The user facility reported that the microguide wires could not pass through the microcatheter during the operation.The procedure was completed with a new set and was successful.The patient was not harmed.

Manufacturer Narrative

G4: 510(k) no:k033583, k033913.Investigation of the actual sample: the actual sample was in the state that the catheter and the guidewire were combined.The outer layer coat of actual guidewire had been peeled off.1.1.Actual catheter.No anomaly such as a scratch or deformation was found along the entire length of catheter.No anomaly such as an obstruction or a crush was found in the lumen of catheter.The coil had been jumbled inside the strain relief.In addition, the foreign substance was adhered at the involved section.The strain relief was disassembled.It was found that the catheter had been buckled.In addition, black substance was found inside the catheter.The black substance was collected and component analysis was performed.As a result, the spectrum was similar to that of the outer layer coat of guidewire.Therefore, it was inferred that the outer layer coat of guidewire was peeled off at the involved section.1.2.Actual guidewire.The outer layer coat had been peeled off at approximately 820mm, 840 - 850mm, and 860mm from the distal end.The peeled section of outer layer coat had been flared and abraded toward the distal side.No anomaly such as a scratch or deformation was found other than the peeled section of guidewire.The outer layer coat of actual sample was intentionally peeled off and the adhesion was confirmed.No anomaly such as floating or a gap was found.1.3.Combination test.An attempt was made to insert the actual guidewire into the actual catheter.It got caught inside the strain relief and could not be inserted.Function confirmation: inner diameter of the actual catheter: it met the factory's specifications.No anomaly was found.Outer diameter of the actual catheter: it met the factory's specifications.No anomaly was found.Outer diameter of the actual guidewire: it met the factory's specifications.No anomaly was found.History investigation: the manufacturing record and the shipping inspection record of the product with the involved product code/lot#: no anomaly was found.Past complaint file of the product with the involved product code/lot#: no other similar report from other facilities was found.4.Simulation test: simulation test of this event was performed in the past.4.1.Using factory-retained progreat, the guidewire was removed vigorously from the catheter with insufficient priming.As a result, resistance occurred.4.2.The guidewire was continuously removed under resistance.Buckling occurred in the vicinity of adhered section between the catheter and the hub inside the strain relief.4.3.It was found that since the surface of guidewire was abraded at the buckled section of catheter, the outer layer coat on the surface of guidewire was peeled off, and the peeled outer layer coat was flared toward the distal side.5.Cause of occurrence/conclusion: based on the investigation result and simulation test result, as a possible cause of this case, the following mechanism was inferred.5.1.When removing the guidewire attached to the actual sample, priming was insufficient, resulting in high frictional resistance between the inner surface of catheter and the outer surface of guidewire.Since the guidewire was removed in that state, the catheter buckled in the vicinity of adhered section between the hub and the catheter inside the strain relief.5.2.Since the surface of guidewire was abraded at the buckled section of actual catheter, the outer layer coat was peeled off.In addition, peeled outer layer coat adhered to the inside of buckled section of the catheter.5.3.The actual guidewire was reinserted into the actual catheter.It got caught at the buckled section of the catheter and could not be inserted.Relevant instructions for use (ifu) reference: "-prime the catheter and guide wire sufficiently.Manipulation of an insufficiently primed catheter may cause wrinking, separation of the catheter, and/or abrasion of the hydrophilic coating on the guide wire.Make sure that the lock adapter is not loose.Inject heparinized saline solution into the guide wire hub using the attached 2.5 ml luer lock syringe.In order to prime the catheter sufficiently, slowly inject at least 1 ml of the solution into the catheter until more than 10 drops of the solution appear out of its tip.To maintain surface lubricity, immerse the catheter and the guide wire assembly in a heparinized saline solution bath or put it into its holder filled with heparinized saline solution." terumo medical products (tmp) (importer) registration no.2243221 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: TERUMO 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17831542
• MDR Text Key: 324456222
• Report Number: 9681834-2023-00185
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/27/2023

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: MC-PE27131
• Device Lot Number: 220524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• 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
• Patient Age: 65 YR
• Patient Sex: Male