MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS GLIDECATH HYDROPHILIC COATED CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

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

Patient Problem Cardiogenic Shock (2262)

Event Date 12/21/2021

Event Type  Death  

Manufacturer Narrative

Expiration date: unknown due to unknown catalog and lot number combination, udi: unknown due to unknown catalog and lot number combination, implanted date: device was not implanted, explanted date: device was not explanted, device manufacture date: unknown due to unknown catalog and lot number combination.The actual samples were not available therefore, an evaluation of the actual device was unable to be conducted.Since the product code and lot number for the involved products were unknown, the manufacturing record and shipping inspection record cannot be investigated.Search of the complaint files of the past five (january 2018 - january 2023) years regarding each product type found no cases of a patient's death due to product defects.We attempted to obtain additional information on the details of the usage status, failure, and damages that led to the death of the patient, however, no information could be obtained.In addition, the causal relationship between the reported death of the patient and each product used was unknown.The cause of occurrence could not be clarified.This report is for the third device reported, for the frist and second device reported that was used on the same patient see mdr 9681834-2023-00001, and 9681834-2023-00002.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

Terumo medical received a letter from a law office stating that: (i) terumo products and/or devices were used or attempted to be used during a cardiac procedure and one or more of products and/or devices allegedly failed, individually and/or in combination with one another, causing alleged damages; (ii) the products and/or devices used was a terumo finecross catheter and runthrough ns extra floppy coronary guidewire, takeru ptca balloon dilatation catheter, and a glidewire hydrophilic coated guidewire; (iii) decedent suffered catastrophic cardiac complications and died on (b)(6) 2021.The event occurred post procedure.It was reported that the patient didn't have any blood loss.There is a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• 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: 16260204
• MDR Text Key: 308344381
• Report Number: 9681834-2023-00003
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2023

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: RUNTHROUGH NS EXTRA FLOPPY CORONARY GUIDEWIRE; TAKERU PTCA BALLOON DILATATION CATHETER; TERUMO FINECROSS CATHETER
• Patient Outcome(s): Death
• Patient Sex: Male