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

Model Number G17870

Device Problems Deflation Problem (1149); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It is reported during a sonohysterosalpingography using a cook silicone balloon hysterosalpingography injection catheter, the balloon didn't deflate properly and a piece of the balloon remained in the patient's uterus causing her pain.A hysteroscopy was performed to removed the device fragment due to this.No additional consequences to the patient have been reported as a result of this occurrence.Additional details regarding the patient and the event have been requested.At this time, no additional information has been provided.

Event Description

Additional information was provided: it was reported, the balloon had become detached and had remained inside the uterus, causing severe pain to the patient, who had to undergo an emergency hysteroscopy.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable additional information: b5.Investigation evaluation: reviews of complaint history, device history record, manufacturing instructions, quality control data and the instructions for use(ifu) were conducted during the investigation.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.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions "do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture." "refer to product label of the inflation check valve on the balloon device for appropriate balloon volume." instructions "4.Cleanse the cervix with an appropriate cleansing solution." "5.Catheter tip is inserted through cervix and into uterus." "6.Fill the syringe with sterile saline solution.Eliminate air from the syringe." "7.To inflate the balloon, instill sterile saline solution." "8.Pull back gently on the catheter shaft to seat the inflated balloon against the cervical os." "9.Inject saline through catheter into uterus." "10.Deflate the balloon when the examination is complete and remove the catheter from the cervix." how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." the complaint was confirmed based on the customer¿s testimony.The cause of the events is unknown.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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: 8677312
• MDR Text Key: 147305269
• Report Number: 1820334-2019-01301
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002178700
• UDI-Public: (01)00827002178700(17)220109(10)9432727
• 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: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: G17870
• Device Catalogue Number: J-CHSG-703000
• Device Lot Number: 9432727
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other