MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GS B-KIT 5FR .021 10CM; INTRODUCER, CATHETER

Catalog Number	40-1050
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has not 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.A review of the device history record of the product code/lot number combination was conducted with no relevant findings.A search of the complaint file found one similar report with the involved product code/lot number combination.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 has not been received.
Event or Problem Description
This report is being submitted in response to (b)(4) which was received from the fda on 5/17/17.The event description states the following: "balance middle weight guide wire was loaded in the glidesheath.Bmw wire broke inside patients arm.When glidesheath was removed, tip of glidesheath was bent.Cardiologist managed to retrieve the broken wire and patient not injured.It was the wire that broke, no issue with glidesheath.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to cancel mdr report no.1118880-2017-00038 that was submitted on june 15, 2017.This report was inadvertently submitted and is not an fda reportable event.

• Brand Name: GS B-KIT 5FR .021 10CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 6642953
• Report Number: 1118880-2017-00038
• Device Sequence Number: 1122888
• Product Code: DYB
• UDI-Device Identifier: 30389701011036
• UDI-Public: (01)30389701011036(17)180930(10)UE27
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 40-1050
• Device Lot Number: UE27
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR