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

Model Number N/A

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

Patient Problems Death (1802); Perforation of Vessels (2135)

Event Date 11/13/2019

Event Type  Death  

Manufacturer Narrative

Expiration date: unknown due to unknown product code/ lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown product code/ lot number.Pma/510(k)- unknown due to unknown product code/ lot number.Patient height: 71 inches.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The production product code and lot number were not provided by the user facility, which prevented a meaningful review of the device history record and shipping inspection records.(b)(4).Please see mdr 2243441-2020-00035 for the importer report.

Event Description

The user facility reported an unknown terumo jacky catheter was used during the uncomplicated cardiac catheterization procedure.Per letter from law office, autopsy and cardiac catherization record: the patient was found to have a 1.1.Cm perforation of his left ventricle.The patient with multiple chronic illnesses comes to the hospital complaining of shortness of breath for about two weeks.The patient undergoes a cardiac catheterization procedure to see if the shortness of breath is due to blockages in his coronary arteries.In the procedure they access his right radial artery, take pictures of his left and right coronary arteries, measure blood pressures in different chambers of his heart.The doctor opts not to perform a left ventriculography, since the patient is due to have an echocardiogram (another test using ultrasound on his heart) at another time.They remove the catheter, as well as all other concomitant equipment, they place a tr band on his wrist.The procedure is completed.From the time the patient was in the procedure room to procedure completion was 21 minutes.The patient was walking to the bathroom several hours later and that is when he experienced a cardiac arrythmia and collapsed to the floor where he was coded ( tried to be brought back to life) cpr was performed ( chest compressions, and mechanical ventilation) for over thirty minutes and the patient died.The physician who performed the procedure, gave a legal statement where he believed that the patient experienced the arrythmia due to his pre-existing cardiomyopathy and not from a perforated heart muscle.Arrythmias are a natural risk of having uncontrolled cardiomyopathy.In his medical opinion he believed that the perforation in the patient's heart that was noted on autopsy was caused by the chest compressions during cpr, in which, it is likely that the heart experience trauma.Area of heart/time/pressure: lv (s/d/e) (pressures mmhg), 15:37 149/ -11/12, 15:37 109/ -10/6, 15:37 162/ -7/9.Ao (s/d/m) (pressures mmhg), 15:37 133/58/86, 15:32 111/97/103, 15:32 -/-/-.Vital signs during the procedure (time/heart rate/ blood pressure (mmhg) (systolic- diastolic - mean)/ oxygen saturation/ respiratory rate): 15:25/ 84/ 204\74\117/ 94/ 16, 15:29/ 79/ 173\81\112/ 92/ 16, 15:34/ 79/ 158\77\ 104/ 89, 15:39/ 78/ 165\80\106/ 91.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: UNK CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10296170
• MDR Text Key: 199501500
• Report Number: 9681834-2020-00131
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.035 J-TIP 260 CM GUIDEWIRE CORDIS; 55ML OF ISOVUE 370MG; 5FR OPTITORQUE JACKEY RADIAL 3 5 CATHETER TERUMO; 6FR GLIDESHEATH SLENDER 10 CM TERUMO; ANGIO PACK CARDIAC; FENTANYL 50MCG IV; HEPARIN 5000 UNITS IV; LIDOCAINE 1MG IV; MIDAZOLAM 2MG IV; TERUMO TR BAND; VERAPAMIL 3 MG IV; 0.035 J-TIP 260 CM GUIDEWIRE CORDIS; 55ML OF ISOVUE 370MG; 5FR OPTITORQUE JACKEY RADIAL 3 5 CATHETER TERUMO; 6FR GLIDESHEATH SLENDER 10 CM TERUMO; ANGIO PACK CARDIAC; FENTANYL 50MCG IV; HEPARIN 5000 UNITS IV; LIDOCAINE 1MG IV; MIDAZOLAM 2MG IV; TERUMO TR BAND; VERAPAMIL 3 MG IV
• Patient Outcome(s): Death
• Patient Age: 50 YR
• Patient Weight: 125