MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA GLIDECATH II; CORONARY GUIDING CATHETER

Catalog Number RF-WL15010

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

Patient Problems Hemorrhage, Cerebral (1889); Thrombosis (2100)

Event Date 09/25/2014

Event Type  Injury  

Event Description

The user facility reported that a radifocus glidecath was used during a procedure that resulted in the patient having a mild stroke.The procedure was completed successfully, and it was reported that there was no harm to the patient who is currently under observation.No additional event details have been provided by the user facility.

Manufacturer Narrative

(b)(4).Other serious - the user facility information indicated that the patient suffered a mild stroke during the procedure.The actual device was not returned for evaluation and the involved lot number is unknown.Therefore, the investigation and evaluation were limited to user facility information and evaluation of a retention sample.Visual inspection did not find any anomalies, including a kink or break, along the total length of the shaft.Magnifying inspection did not find any anomalies, including a scratch or exposure of the braided wire, which could cause thrombus to form.The inside and outside diameters were measured and product specifications were met.Electron microscopic inspection of the inner and outer surfaces of the shaft did not reveal any anomalies which could cause the formation of thrombus.Based on user facility information and evaluation results of the retention sample, the cause for the reported event cannot be definitively determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.(b)(4).Device not available.

• Brand Name: GLIDECATH II
• Type of Device: CORONARY GUIDING CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 4103927299
• MDR Report Key: 4195330
• MDR Text Key: 4985648
• Report Number: 9681834-2014-00263
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2014,10/23/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: RF-WL15010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/25/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2014
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 10/23/2014
• 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
• Patient Outcome(s): Other