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

Catalog Number RF-XL95110L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paralysis (1997); Thrombosis/Thrombus (4440)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k122590, k915414.The actual sample and the concurrently used radifocus guidewire m were discarded by the user.Four samples of the involved product code/lot# were returned from the facility's stock.Inspection of the four returned samples of the involved product code/lot# combination.The retuned samples are called sample a, sample b, sample c, and sample d in this report and inspected as follows.Visual inspection and magnifying inspection of sample a through d revealed that the hydrophilic coating sections had no kinks, no crushes, or no other visible anomalies.The other sections other than the hydrophilic coating sections also had no kinks, no crushes, or no other visible anomalies.Lubricity of the area 0 mm - 400 mm from the distal end was confirmed by tactile sensory test.No frictional resistance was perceived from sample a through d, which indicated that the hydrophilic coating had been applied properly to all of them.X-ray fluoroscopic inspection of sample a through d revealed no anomaly such as an obstruction in them.The inside and outside diameters were measured.It was confirmed that sample a through d met the specifications.Review of the manufacturing record and the shipping inspection record of the involved product code/lot# combination confirmed that there were not any problems in them.A search of the complaint file found no similar report with the involved product code/lot# combination from other facilities.The investigation result verified that sample a through d had no anomaly in the dimension and in the lubricity performance.With no actual sample returned for evaluation, the cause of occurrence could not be clarified.Ifu states: consider the use of systemic heparinization to prevent or reduce the possibility of thrombus formation on the surface of the catheter.This report is for the rf-xl95110l reported, for the radifocus guidewire m device reported that was used in combination with the actual device see mdr 9681834-2020-00223.(b)(4).

Event Description

The user facility reported that the involved radifocus glidecath was used during the cerebral angiography (cag) case.Thrombus occurred.The procedure outcome was not reported.The patient had paralysis in the area beyond his/her left wrist, additional information was received on 07oct2020.Harm to the patient could not be confirmed.Additional information was received on 08oct2020.Cerebral infarction appeared in the patient.Additional information was received on 13oct2020.Pre-operative cag for coil embolization in cerebral aneurysm 2000 unit of heparin and 45 ml of iomeprol 300 were used.After the bed rest level was alleviated, (after 5 or 6 hours) they noticed an abnormality of the patient.On oct 6, mri was taken, and cerebral infarct was confirmed.The patient was discharged, although paralysis of thumb remains.Rehabilitation was carried out.Additional information was received on 15oct2020.Cag was performed pre-operative.The planned procedure/treatment was a coil embolization of the cerebral aneurysm.0.035" radifocus was used because of femoral approach (they use 0.032" radifocus if it is brachial approach.In case of routine cag, 2000 unit of heparin is used.No other drug was used.The doctor suspected that the coating had peeled off.They did not notice the thrombus during cag, it was after the operation (in 5 to 6 hours after the operation, when the bed rest was released), they noticed the patient's abnormality and took an mri to confirm the cerebral infarction.No additional cag was performed, and follow-up observation was performed.A recovery tendency was confirmed.The patient had paralysis in the area beyond his left wrist, when discharged their symptoms other than the thumb recovered.The patient was discharged.Currently, the paralysis of the thumb remains, so outpatient rehabilitation was carried out.Coil embolization for cerebral aneurysm was planned to be performed within this year (in three months from cag), but the treatment date has been postponed to the beginning of the year.

• Brand Name: RADIFOCUS GLIDECATH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10780439
• MDR Text Key: 216723339
• Report Number: 9681834-2020-00217
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K090040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: RF-XL95110L
• Device Lot Number: 191101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• 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; Required Intervention