MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER

Model Number N/A

Device Problem Use of Device Problem (1670)

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

Event Date 04/09/2015

Event Type  Death  

Event Description

The user facility reported an aorta perforation using the radifocus optitorqus device.Follow up communication with the user facility reported the following information: the liver biopsy resulted in intraperitoneal bleeding; to arrest hemorrhage emergency angiography was performed; (3) however, the patient expired; and it was reported bleeding may have become worse due perforation of the aorta.

Manufacturer Narrative

This section was completed by the manufacturer per cfr 803.52(f) (11) because the information was not initially completed by the user facility.This one reported event is being reported on the following mdr reports: 9681834-2015-00081, 9681834-2015-00082, 9681834-2015-00083 and 9681834-2015-00085.The actual sample was not returned to the manufacturing facility for evaluation and the lot number is unknown.Therefore, the investigation was based on the evaluation of user facility information, and the evaluation of a product sample.Visual inspection did not find any anomalies.Visual inspection of the shaped segment did not reveal any anomalies.Magnifying inspection of the distal end confirmed that the chamfering and rounding processing had been done correctly.Electron microscopic inspection of the distal segment did not find any anomaly.The inside and outside diameters were measured on the distal segment and confirmed to meet manufacturer specifications.The kink resistance was determined and confirmed to be normal.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and the shipping inspection record.A review of the complaint files were conducted back two years (from may, 2013 to april, 2015) and found no reports of perforation of the aorta.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified the samples evaluated were of the normal product.With no return of the actual sample to evaluate, the cause of the reported perforation of the vessel cannot be determined from the available information.The potential for such an event is addressed in the warnings / precautions section of the instructions-for-use by statements such as the following: never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.Failure to exercise proper caution may result in damage to the vessel or catheter.Separation of the catheter may occur requiring retrieval in some cases.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 returned to manufacturer.

• Brand Name: RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
• Type of Device: 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 ; 8002837866
• MDR Report Key: 4765244
• MDR Text Key: 5786154
• Report Number: 9681834-2015-00084
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2015,05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RH-AG94007
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2015
• Date Manufacturer Received: 04/21/2015
• 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): Death