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

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

The user facility reported that the guidewire could not pass through the catheter.The microcatheter was withdrawn from the blister package and the container tube was flushed with normal saline.The attached microwire was withdrawn.After flushing microcatheters lumen with normal saline, the guidewire was not able to be inserted back inside the microcatheter.No patient was involved.The event occurred before use, therefore there was no risk as serious injury.The procedure outcome was not reported.The final patient impact was not harmed.The event occurred pre-treatment.

Manufacturer Narrative

G4: pma/510(k): k033913 the actual sample upon receipt was a progreat catheter and a guidewire integrated type.Appearance confirmation of catheter: no anomaly such as a kink was found along the entire length of catheter (magnifying inspection).No anomaly such as an obstruction or jumbling of reinforcement coil was found in the catheter (x-ray fluoroscopic inspection).The reinforcement coil had been jumbled inside the strain relief.In addition, the foreign substance was adhered at the involved section (x-ray fluoroscopic inspection).The strain relief of actual sample was disassembled.It was found that the catheter had been buckled.In addition, black substance was found inside the catheter (magnifying inspection).Component analysis: the black substance adhered to the inside of the buckled section of catheter was collected and component analysis was performed.It was similar to the spectrum of the outer layer coat of guidewire integrated type (ft-ir).It was likely that the main component of black substance was the outer layer coat of guidewire.Ft-ir (fourier transform infrared spectroscopy method): an analysis method analyzing the spectrum obtained by irradiating the measurement target with infrared rays.Appearance confirmation of guidewire integrated type: it had been roughened at approximately 1465mm from the distal end (magnifying inspection).Multiple abrasions toward the distal direction were found at the involved section (electron microscopic inspection).It was inferred that the involved section was abraded at the buckled section of catheter when the guidewire integrated type was removed.Combination test: an attempt was made to insert the guidewire integrated type into the actual catheter.It got caught at the hub section and could not be inserted.It was inferred that it got caught at the bucked section of catheter.Function confirmation: inner 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.The manufacturing record and the shipping inspection record of the product with the involved product code/lot number found no anomaly.Past complaint file of the product with the involved product code/lot number found no other similar report from other facilities.Simulation test of this event was performed in the past: using factory-retained progreat, the guidewire was removed vigorously from the catheter with insufficient priming.As a result, resistance occurred.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.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.Based on the investigation result and simulation test result, as a possible cause of this case, the following mechanism was inferred.When removing the guidewire integrated type, 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.The surface of guidewire integrated type was abraded at the buckled section of actual catheter, causing the outer layer coat of guidewire to peel off.In addition, the peeled outer layer coat adhered to the buckled section of catheter.The guidewire integrated type was reinserted into the actual catheter.As a result, it got caught at the buckled section of 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.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: 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 ; 4103927218
• MDR Report Key: 18299893
• MDR Text Key: 330140534
• Report Number: 9681834-2023-00259
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: Other
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MC-PP24151ZV
• Device Lot Number: 230125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 76 KG