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

Catalog Number J-CHSG-703001

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

During the procedure, the cook silicone balloon hysterosalpingography injection catheter was inflated successfully; however when it was time for removal the balloon would not deflate.The user was able to remove the balloon by cutting the port at the bottom.The user elected to open a 2nd cook silicone balloon hysterosalpingography injection catheter to test it before using it before continuing on with the procedure; however the very same difficulty occurred.The procedure was completed with the 1st complaint device as this was towards the end of the procedure.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a cook silicone balloon hysterosalpingography injection catheter was not returned/received for an evaluation.The customer report that the balloon would not deflate could only be confirmed based on the customer¿s testimony.Based on the information available a definitive root cause could not be established.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.A review of the device history record could not be performed due to the lot number was not provided.A review of complaint history for the associated lot could not be performed due to the lot number was not provided.Measures have been initiated to address this failure mode.Per the quality engineering risk assessment; no further action is required.Cook medical has notified the appropriate personnel and the will continue to monitor this device via the complaints database 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: 5879968
• MDR Text Key: 52285038
• Report Number: 1820334-2016-00794
• Device Sequence Number: 1
• Product Code: HES
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K891290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-CHSG-703001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention