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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)

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COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES) Back to Search Results
Model Number G17147
Device Problems Balloon (419); Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/26/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

 
Event Description

It is reported during an unspecified procedure using a cook silicone balloon hysterosalpingography injection catheter, the balloon was burst and would not inflate. The procedure was completed with another device. The patient did not experience any adverse effects as a result of this occurrence. Additional details have been requested regarding the patient and event. At this time, no additional information has been provided.

 
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Brand NameCOOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
Type of DeviceHES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC.
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10110936
MDR Text Key198140967
Report Number1820334-2020-01048
Device Sequence Number1
Product Code HES
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK891290
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG17147
Device Catalogue NumberJ-CHSG-503000
Device LOT Number13047357
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/12/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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