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

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
A hysterosalpingography procedure was being performed.After inflation of the device, difficulty was experienced when the physician was unable to remove the device from the patients body.The doctor had to cut the device for it to be released and taken out.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.(b)(4).Investigation - evaluation a review of the complaint history, instructions for use (ifu), device history record, documentation, manufacturing instructions, specifications and quality control of the device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as the proper warnings, precautions, and instructions for use.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the information provided, no product returned and the results of our investigation, the physician was unable to remove the device from the patients body after the inflation of the device.The doctor had to cut the device for it to be released and taken out.No adverse effects to the patient were reported due to this occurrence.We will continue to monitor for similar complaints.Per the quality engineering risk assessment measures have been previously conducted to address this issue.
Event or Problem Description
A hysterosalpingography procedure was being performed.After inflation of the device, difficulty was experienced when the physician was unable to remove the device from the patient's body.The doctor had to cut the device for it to be released and taken out.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
• Common Device Name: HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5584711
• Report Number: 1820334-2016-00247
• Device Sequence Number: 16483679
• Product Code: HES
• UDI-Device Identifier: 00827002174719
• UDI-Public: (01)00827002174719(17)190303(10)6786867
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K891290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-CHSG-703001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2016
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2016
• Supplement Report FDA Received Date: 11/14/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention