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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 N/A
Device Problems Inflation Problem (1310); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

 
Event Description

It was reported that prior to performing hysterosalpingogram (hsg), the physician tested a cook silicone balloon hysterosalpingography injection catheter and found that the balloon did not inflate completely. Only the half side of the balloon was seen inflated. It is unknown if the physician completed the intended procedure. No unintended section of the device remained inside the patient's body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Additional information was requested regarding this occurrence; however it is not available at this time.

 
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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 Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6681120
MDR Text Key78982903
Report Number1820334-2017-01593
Device Sequence Number1
Product Code HES
Combination Product (Y/N)N
Reporter Country CodeES
PMA/PMN NumberK891290
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberJ-CHSG-503000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/07/2017
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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