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

Catalog Number J-CHSG-503000

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2017

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

The user facility reported while using the cook silicone balloon hysterosalpingography injection catheter, the balloon could not be deflated and the catheter had to be cut off.As reported, no portion of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Additional patient, device and event details have been requested but not received as of the date of this report.

Manufacturer Narrative

Additional information was provided regarding this device issue report.It was reported that this event occurred during testing of the device outside of the patient.The balloon was inflated with air, would not deflate and it was not used on the patient.As the catheter was damaged (catheter could not be blocked), a second one was used for the 'hysterosalpingokontrastsonography' and worked very well.Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), specifications, and quality control of the returned device was conducted during the investigation.No issues were found related to the reported complaint.The cook silicone balloon hysterosalpingography injection catheter was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and one non-conformance was noted for the work order having incorrect, incomplete or missing information.There were no non-conformances related to the reported issue of user being unable to deflate the balloon.A review of complaint history revealed there have been no other complaints associated with this complaint device lot number.The instructions for use (ifu) provides the following warning: always inflate the balloon with a sterile liquid.Never inflate with air, carbon dioxide or any other gas.Based on the provided information, a definitive root cause can be established as user technique.Measures have been initiated to correct this issue.Monitoring will continue to be performed for similar complaints.

• Brand Name: COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
• Type of Device: HES 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 Key: 6799876
• MDR Text Key: 82868415
• Report Number: 1820334-2017-02527
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)200202(10)7643383
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K891290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-CHSG-503000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• Date Device Manufactured: 02/02/2017
• 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