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

Model Number G17147

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(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 is reported during a hysterosalpingogram (hsg) procedure using a cook silicone balloon hysterosalpingography injection catheter, after inflating the device with air, the user had difficulty deflating the device to remove it from the patient.The procedure was completed using the complaint device.No unintended section of the device remained inside the patient, and the patient did not require any additional procedures as a result of this occurrence.There were no adverse effects to the patient.Additional details regarding the patient and the event have been requested.At this time, no additional information has been provided.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during a hysterosalpingogram (hsg) procedure using a cook silicone balloon hysterosalpingography injection catheter, after inflating the device with air, the user had difficulty deflating the device to remove it from the patient.The procedure was completed using the complaint device.No unintended section of the device remained inside the patient, and the patient did not require any additional procedures as a result of this occurrence.There were no adverse effects to the patient.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.No physical examinations could be conducted.A document-based investigation evaluation was performed.No related non-conformances were found.One additional complaint for this product lot has been received, captured in manufacturer report # 1820334-2020-01568.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use which warn, "always inflate the balloon with a sterile liquid.Never inflate with air, carbon dioxide or any other gas." based on the information available, cook has concluded that the user¿s failure to follow instructions, using air to inflate the balloon, contributed to this event.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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: 10362375
• MDR Text Key: 201601409
• Report Number: 1820334-2020-01423
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)230505(10)13172552
• Combination Product (y/n): N
• PMA/PMN Number: K891290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2023
• Device Model Number: G17147
• Device Catalogue Number: J-CHSG-503000
• Device Lot Number: 13172552
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1