MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA FINECROSS MG; CATHETER

Catalog Number NC-F863A

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

The udi number for this product code is not required to be registered.The actual device was returned to the manufacturing facility 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 and shipping inspection records of the involved product/lot number combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot number combination.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

The user facility reported the device tip separated during a procedure.Follow up communication with the user facility confirmed the following information: the distal tip tore off; the distal marker and tip was in the patient; and the patient was reported to have minor harm.

Manufacturer Narrative

This report is being submitted as follow up number 1 to provide the returned sample evaluation results as well as additional information received.The actual device was returned to the manufacturing facility for evaluation.Visual inspection found that the distal segment of the shaft had been fractured.Magnifying inspection of the distal fractured end found the outer layer and the reinforcement had been fractured with the outer layer having been elongated at the fracture end.Comparison of the distal end with the current finecross mg product sample found the distal tip and the gold coil maker were missing from the actual sample.Magnifying inspection of the segment from the distal fracture end to the distal end of the strain relief found the shaft had been elongated on 0 mm - approximately 150 mm from the fracture end of the outer layer.Due to the generation of the elongation on the shaft the exact length of the separated and missing distal segment was not determined.Electron microscopic inspection of the segment adjacent to the fracture revealed some abrasions generated in the distal and circumferential directions on 0 - approximately 10 mm from the fracture end of the outer layer.The abrasions in the circumferential direction implies that the actual sample was subjected to some torque force in the state of the distal segment being trapped and abraded by the hard object, including the calcified lesion, when attempts to release the trap were made.The outside diameter was determined on the undamaged segment and confirmed to meet manufacturing specification.Simulation testing was conducted.A factory retained finecross mg sample was inserted into a phantom vessel over a factory retained runthrough ns sample (0.014 inch wire).As a simulation of a trap of the device in the lesion, the distal segment of the finecross mg was trapped by forceps together with the runthrough ns inserted in it.In this state, a pulling force was applied to the finecross mg in the direction of withdrawal.The finecross mg became elongated on 0 mm - 150 mm from the distal end of the device with the generation of a fracture of the outer layer and the reinforcement at approximately 5 mm from the distal end.The outer layer was noted to have been elongated at the fracture end in the manner similar to the actual sample.There is no evidence that this event was related to a device defect or malfunction.While an exact cause of the reported event cannot be definitively determined based on the available information, it is likely the actual sample came into contact with a hard object, including the calcified lesion and became trapped.In this state, attempts to withdraw the actual sample was made resulting in the reported event.The device labeling does address the potential for such an event in the instruction for use (ifu) with statements such as the following: "remove the product, the guide wire and the guiding catheter altogether if any resistance is felt while withdrawing the product." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The following additional information was received on may 24, 2017.Patient referred to rotablation after previous failed balloon angioplasty.Lesion in mid rca, 20 mm size, 95% stenosis with severe calcification, no tortuosity.No predilatation.After crossing the lesion with a guidewire.The tip was stuck in the calcified lesion and would not proceed.During removal of finecross from the lesion the tip was lost, just a little excessive force was used.Event did delay procedure.Balloon angioplasty was attempted, unable to cross with rotawire without microcatheter.Only 1.5 mm balloon would cross the lesion without proper dilation.Anchoring balloon and body wire techniques were used without success.Guideliner was deployed for additional support but didn't add to the success.During the second attempt on the lesion corsair microcatheter was successfully used.This procedure was unsuccessful.Second attempt was made a week later and was finished with rotablation and successful stenting.The tip remaining in the patient made it more difficult for other equipment to pass (wires, balloons).The adverse consequences was permanent for the duration of the current procedure.During the second attempt the tip was dislodged distally, pushed forward by corsair and dislodged to a distal pda causing no further complications.Follow-up treatment is needed.There was no blood loss.

• Brand Name: FINECROSS MG
• Type of Device: CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6613069
• MDR Text Key: 76710616
• Report Number: 9681834-2017-00112
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K082519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: NC-F863A
• Device Lot Number: 170116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• 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 Outcome(s): Other