MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.; WIRE, GUIDE, CATHETER

Model Number	CG416
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device has been returned to the manufacturer facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, (b)(4) has been referenced in the conclusions section of evaluation codes.A review of the device history record and the shipping inspection record of the product code/lot# combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported the following that was received through a user facility medwatch (b)(4)."difficult removal of ivc filter in operatin room (or).Ivd filter had been placed months earlier prior to a gastric bypass.The removal procedure was prolonged (two hours) as opposed to a typical 30 minutes.A standard protocol chest x-ray post-surgery revealed the retention of a foreign body in pulmonary artery.Successful retrieval by interventional radiologist of 37 cm foreign body which appears to represent a "stretched, fractured section" of a glidecath (angiographic catheter).What was the original intended procedure? removal of ivc filter." "it was a difficult ivc filter removal requiring several attempts by initial surgeon and then subsequently, the interventional surgeon.: it was reported that "yes, there is a possibility that the ivc filter removal may have sheared the cath." additional information was received on july 28, 2017.The patient was reported to be stable and doing well.They successfully removed the ivc filter and had a successful removal of the retained product.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.It was reported in the initial report that the device was available for evaluation.It has now been determined that the actual device is no longer available for evaluation.No evaluation could be conducted due to the device not being returned.There is no evidence that this event was related to a device defect or malfunction.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6792347
• Report Number: 9681834-2017-00175
• Device Sequence Number: 1038686
• Product Code: DQX
• UDI-Device Identifier: 04987350772213
• UDI-Public: 04987350772213
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K915414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: CG416
• Device Catalogue Number: RF*ZV94110A
• Device Lot Number: 170218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 127