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

Catalog Number RF-WE14010

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

Patient Problem No Code Available (3191)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

Udi: not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k915414.(b)(4).The involved device was not returned for evaluation.Therefore, the investigation was based on user facility information and evaluation of the retention sample.Visual inspection of the retention sample from the involved product code/lot# combination revealed that the were no anomalies, including a kink or crush, over the entire length.The outer and inner diameter were measured and confirmed to meet the manufacturer specifications.The tapered part of the two-way stopcock was measured, and no anomaly was observed.A review of the device history record and shipping inspection records of the involved product code/lot# combination was conducted with no findings.The investigation results verified that the retention sample was normal product.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported the involved radifocus glidecath and a predura three-way stopcock (top) were used for cerebral angiography.The procedure was performed in the usual way and finished without any problem.After the procedure was finished, the patient had anomaly and developed aphasia.The possibility cannot be ruled out that aphasia had developed before the procedure.At the time of pre-procedure id check, the patient could not respond verbally to the questions, and responded by nodding.The procedure was completed successfully.

• Brand Name: RADIFOCUS GLIDECATH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, md ; 2837866718
• MDR Report Key: 10269762
• MDR Text Key: 202233843
• Report Number: 9681834-2020-00128
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: RF-WE14010
• Device Lot Number: 190107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2019
• 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