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

Catalog Number 40-1050

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2017

Event Type  malfunction  

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 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.".

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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 2101 cottontail lane; somerset NJ 08873
• Manufacturer Contact: terry callahan ; 2101 cottontail lane; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6642953
• MDR Text Key: 77628026
• Report Number: 1118880-2017-00038
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 30389701011036
• UDI-Public: (01)30389701011036(17)180930(10)UE27
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 40-1050
• Device Lot Number: UE27
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2016
• 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 Age: 74 YR