COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER G17870 J-CHSG-703000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-27 for COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER G17870 J-CHSG-703000 manufactured by Cook Inc.

Event Text Entries

[177399120] (b)(6). Occupation: manager of diagnostic imaging. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[177399121] It was reported, prior to an xray hysterosalpingogram using a cook silicone balloon hysterosalpingography (hsg) injection catheter, the device would not deflate. The physician tested the device prior to use on the patient by inflating with 1. 5ml of air, but it failed to deflate. Another same type hsg device was tested and used to complete the procedure. No adverse effects were reported due to the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2020-00207
MDR Report Key9631285
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-27
Date of Report2020-02-17
Date of Event2020-01-17
Date Mfgr Received2020-02-14
Device Manufacturer Date2019-07-12
Date Added to Maude2020-01-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUNK JENNIFER CANADA
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
Generic NameHES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)
Product CodeHES
Date Received2020-01-27
Returned To Mfg2020-02-10
Model NumberG17870
Catalog NumberJ-CHSG-703000
Lot Number9877203
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-27

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