MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA FINECROSS MG CORONARY MICRO-GUIDE CATHETER; CATHETER, CONTINUOUS FLUSH

Model Number N/A

Device Problems Peeled/Delaminated (1454); Material Separation (1562)

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

Event Date 05/09/2022

Event Type  Injury  

Manufacturer Narrative

Udi - not required for product code.Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: unknown.Occupation: unknown.Device manufacture date: unknown due to unknown lot number.Visual inspection of the actual sample found that the finecross was combined with the guidewire advantage.The finecross was located approximately 1400 - 2900 millimeters from the distal end of the guidewire advantage.Both devices were inspected.Since the involved lot number was unknown, review of manufacturing records could not be performed.Since the involved lot number was unknown, the manufacturing date is unknown.Inspection of the guidewire advantage obtained the following results: i) magnifying inspection of the guidewire advantage found no scratch or other external anomalies, ii) the outer diameter was measured and confirmed to meet the factory's control standards.No anomaly was observed.Iii) the total length was measured and confirmed to meet the factory's control standards.No portion was missing from the shaft.Inspection of the finecross: magnifying inspection of finecross obtained the following results: i) the outer layer had been elongated in the area from the distal end to 100 mm from the distal end, ii) the outer layer had been fractured at approximately 220 mm from the distal end, iii) in the area proximal from approximately 220 mm from the distal end, the braided wire was exposed, elongation and buckling of braided wire was observed, iv) the proximal end of the braided wire was located at approximately 1500 mm from the distal end of the shaft.X-ray fluoroscopic inspection of the area where the outer layer remained obtained the following results: i) the braided wire had been elongated entirely from the distal end to approximately 220 mm from the distal end, ii) no clogging was found due to foreign substance was observed in the lumen.Electron microscopic inspection found multiple abrasions on the surface.From this, it was inferred that a hard object came into contact with the involved area.An attempt to remove guidewire advantage from finecross was made; however, it could not be removed due to resistance.The outer diameter was measured on the undamaged area and confirmed to meet the factory's specifications.A simulation test confirmed the mechanism of fracture of outer layer and elongation of braided wire of finecross: a guidewire advantage was inserted into a factory-retained finecross.Assuming from the results of analysis that the distal end of finecross was trapped by some hard object, it was trapped and then the proximal side was grasped and pulled.As a result, elongation of the finecross shaft occurred.Further pulling force to the finecross resulted in the fracture of outer layer; in addition, the braided wire became exposed and elongated.Due to this, the finecross was stuck over the guidewire advantage.Based on the investigation results, it was likely that the reported event was caused by the following mechanisms: i) the finecross was exposed to pulling force while its distal end was trapped by some hard object, ii) when the pulling manipulation of finecross was continued, the shaft of finecross was elongated, iii) when pulling force was applied further, the outer layer was fractured, and the braided wire was exposed and elongated, iv) due to the above damage, the lumen of finecross became narrow, which resulted in sticking over the guidewire advantage, v) the finecross in that state was exposed to further pushing and pulling manipulation, the braided wire became buckled degrading the sticking state relevant instructions for use (ifu) reference: "remove the product, the guide wire and the guiding catheter altogether if any resistance is felt while withdrawing the product." "the product (finecross mg) is intended to be percutaneously introduced into blood vessels and support a guide wire in crossing the localized stenotic lesion of the coronary artery while performing pci (percutaneous coronary intervention) in case the guide wire can hardly cross the lesion.The product is also intended for injection of radiopaque contrast media for the purpose of angiography." (b)(4).

Event Description

Upon receipt of the sample on 27 may 2022 for ppr-22-0168 for a guidewire advantage, a piece of the finecross mg catheter was found in the package for the returned sample.Part of the coating was detached, it stripped off the microcatheter.All pieces were completely removed from the patient.The guidewire was replaced by a second advantage device.The event occurred intra-operative.There was no harm to the patient.There was no patient injury/medical or surgical intervention required.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in sections a1, a2, d4, and h6.Review of the manufacturing record and the product-release judgment record of the involved product/lot number combination confirmed that there were not any anomalies in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.

• Brand Name: FINECROSS MG CORONARY MICRO-GUIDE CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: stephanie handy ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14771014
• MDR Text Key: 294494584
• Report Number: 9681834-2022-00116
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: NC-F863A
• Device Lot Number: 210826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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
• Treatment: RADIFOCUS GLIDEWIRE ADVANTAGE
• Patient Age: 59 YR