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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

The event is currently under investigation.A follow up report will be send upon conclusion.

Event Description

It was reported by the user facility that a patient underwent an unspecified procedure using a cook silicone balloon hysterosalpingography injection catheter.The initial reporter indicated that the customer could not drain the balloon with the syringe that was provided in the package.The initial reporter stated that the balloon was able to be filled with the syringe but could not be emptied.It was noted that in order to drain the balloon the physician had to use another luer slip syringe.There were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the drawings, manufacturing instructions, specifications, and quality control was conducted during the investigation.As anticipated, the cook silicone balloon hysterosalpingography injection catheter was not returned for evaluation.No photos have been provided.Without the complaint device, a physical investigation was not able to be completed.The device history record was reviewed and no non-conformances were noted.A review of complaint history for this product/lot number combination revealed this is the only complaint associated with complaint lot number 7455682.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Measures have been conducted to address this failure mode.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: 6473120
• MDR Text Key: 72191775
• Report Number: 1820334-2017-00764
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)191118(10)7455682
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K891290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-CHSG-503000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Date Device Manufactured: 11/18/2016
• 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