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

Catalog Number CG417

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 11/05/2013

Event Type  malfunction  

Event Description

This report is being submitted in response to the medwatch report # (b)(4) which was received from the fda on (b)(4) 2013.The event description states the following: "the catheter was being added to a sterile tray for a stroke case.The catheter was found to be kinked when removed from packaging.It was replaced and no patient harm occurred.".

Manufacturer Narrative

Section f: 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 report is being submitted as a precautionary measure in follow-up to user facility medwatch report # (b)(4), even though the criteria for submission of a mdr were not met based on the available information.The involved device has not yet been received for evaluation.Therefore, the investigation was conducted based on a review of information provided by the user facility, a retained sample and manufacturing quality records.A review of the device history record indicated that there were no production related problems.A review of the complaint files confirmed that this lot number has not been reported previously.There is no evidence that this event was related to a device defect or malfunction.All currently available information has been placed on file by qa at the manufacturing facility for appropriate tracking, trending and follow-up.(b)(4).

Manufacturer Narrative

Results/conclusion are based on evaluation of user facility information & the returned sample; are based upon evaluation of undamaged sections of the returned sample the involved device was returned & evaluated by qa at the manufacturing facility.Examination confirmed that there was a kink at approx.275mm from the distal end of the device.Inspection and testing of the undamaged section of the actual sample found no defects or anomalies and confirmed that product performance specifications were met.A review of the device history record indicated that there were no production related problems for this lot number.A review of the complaint files confirmed that this lot number has not been reported previously.There is no evidence that this event was related to a pre-existing device defect.The event description and appearance of the return sample are consistent with the actual sample being exposed to bending force which exceeded the strength limit of the product after it had been removed from the package card.The device labeling does address the potential for such an event with statements in the directions for use section of the instructions-for-use with statements such as the following: "carefully open the sterile pouch and gently remove the catheter from the package."; and "do not user if the catheter has been damaged or any other anomaly is observed." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

This report is being submitted as follow-up # 1 for mfg.Report # 9681834-2014-00006 to provide the results of the evaluation of the returned sample.

• Brand Name: RADIFOCUS GLIDECATH
• Type of Device: 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 ; 8002837866
• MDR Report Key: 3565713
• MDR Text Key: 4048662
• Report Number: 9681834-2014-00006
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2013,11/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: CG417
• Device Lot Number: 130425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2013
• Distributor Facility Aware Date: 11/05/2013
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2013
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2013
• 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