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 Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was initially reported, during a hysterosalpingography (hsg) the balloon ruptured when the lipidiol fluid was infused into the cavity.Additional information was received 07feb2020: the device was tested prior to contact with the patient and there was no indication that the device was not functioning properly.It was reported, during the procedure the balloon deflated and the catheter came out.The device was tested and they found the balloon would not re-inflate.After the first balloon failed they tried a second balloon with lipiodol.Upon the failure of the second device they switched to a water soluble contrast and a competitors' device to complete the study.There was no harm to the patient.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation it was initially reported, during a hysterosalpingography (hsg) the balloon ruptured when the lipidiol fluid was infused into the cavity.Additional information was received advising, the complaint device was tested prior to use and found to inflate normally.During use, the device was re-inflated using the provided syringe, and the catheter failed to inflate then fell out of position.The device was removed, and inflation was attempted again.Leakage from the balloon was observed.Further communication with the complainant revealed an additional instance of leakage occurred prior to this.The physician was unable to confirm if the balloon ruptured or if it was just leaking.No adverse events were recorded.A document based investigation was performed including a review of the instructions for use and quality control data.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 made out of specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The lot number of the device is not known; accordingly, a review of complaint history could not be conducted.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." a definitive cause of the event could not be determined from the available information.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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
• MDR Report Key: 9693092
• MDR Text Key: 190693203
• Report Number: 1820334-2020-00323
• Device Sequence Number: 1
• Product Code: HES
• Combination Product (y/n): N
• PMA/PMN Number: K891290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-CHSG-503000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1