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

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problem Pain (1994)

Event Date 12/02/2022

Event Type  malfunction  

Event Description

The user facility reported that they performed a hepatic artery embolization operation with the involved progreat device.The coating on the wire tip fell off, causing the clinician to prolong the operation time and the patient's pain.After many operations, the operation effect was not achieved.The wire was cut outside the patient's body.The event occurred intra-operative.The procedure finally completed successfully.The final patient impact was not harmed.The patient was not injured during the event and medical or surgical intervention was not required.

Manufacturer Narrative

Occupation: clinical engineer.Pma/510(k) no: k033583, k033913.The actual device has been returned for evaluation.One progreat integrated guidewire (actual sample) and 1 progreat device was returned.Visual inspection of the actual sample upon receipt.The distal end of actual sample had been deformed, and a part of outer layer was missing.No missing part of outer layer was returned.No anomaly such as a kink or an elongation was found in progreat.Magnifying inspection of the actual sample was conducted.The distal end, gold coil (approximately 1mm) had been unwound and exposed, and the outer layer had been elongated.Sections other than the distal end, no anomaly such as a kink or an elongation was found.Electron microscopic inspection of the distal end of actual sample was conducted.The distal end of the gold coil had been tapered.It was inferred that pulling force was applied.The outer layer section that was cut (top), outer layer had a twisted pattern.The outer layer section that was cut (side), outer layer had been elongated, wrinkled, torn, and dented.From the twisted pattern, elongation, wrinkles, and tear of the outer layer, it was inferred that twisting force and pulling force were applied.However, since the outer layer was elongated, the missing length was unknown.As for the dent on the outer layer, it was inferred that it occurred when some hard object (e.G., stenotic lesion) met the involved section.Magnifying inspection of the distal end of actual sample was conducted after removing the outer layer.The actual sample and the product with the involved product code were confirmed.It was found that the coil pitch of actual sample was opened.It was inferred that pulling force was applied to the gold coil, causing opening in the coil pitch.The winding numbers of the gold coil of actual sample (excluding unwound parts) was 245, and the ones of the product with the involved product code was 265.Difference in the winding numbers between the actual sample and the product with the involved product code was 20.The gold coil length per one winding was approximately 0.11mm.It was inferred that the missing length of gold coil was approximately 2.2mm at maximum.The gold coil was intentionally unwound, and electron microscopic inspection of the state of wire was performed.At the top of wire there were traces of processing.On the side of wire had been tapered.It had the same characteristics as the product with the involved product code, and it was inferred that there was no missing on the wire.The dimensions at the distal end of actual sample met the factory's specifications.No anomaly was found.Review of the manufacturing record and the product inspection record of the actual sample.No anomaly was found.Search of the past complaint file of actual sample was conducted and no other similar report from other facilities was found.Based on the investigation result, as a possible cause of this case, it was inferred that the event occurred by the following mechanism.The distal end of actual sample was trapped by some hard object (e.G., stenotic lesion).Since pulling force was applied to the actual sample while it was twisted, the distal end was deformed, and the outer layer was elongated.At that time, the gold coil was also unwound.Further pulling force was applied, resulting in the fracturing of the outer layer and gold coil.Relevant instructions for use (ifu) reference: if any resistance is felt while removing the guide wire, do not remove the guide wire by force.Drawing back the guide wire against resistance may cause the catheter to kink.Carefully remove the guide wire together with the catheter.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: TERUMO 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16309263
• MDR Text Key: 308924035
• Report Number: 9681834-2023-00005
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: MC-PE27131
• Device Lot Number: 210830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2021
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 65 KG