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 Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Name and address: phone: (b)(6).Fax: (b)(6), name and address: postal code: (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

As reported, during an unknown procedure using a cook silicone balloon hysterosalpingography injection catheter, the balloon broke on the catheter.No known adverse effects have been reported due to the alleged malfunction.Additional patient and event information has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during an unknown procedure using a cook silicone balloon hysterosalpingography injection catheter, the balloon broke on the catheter.No known adverse effects have been reported due to the alleged malfunction.Investigation - evaluation: reviews of the instructions for use and quality control procedures of the device were conducted during the investigation.No device was returned.Accordingly, no physical examinations could be performed.A document-based investigation evaluation was performed.A review of the device history record and complaint history could not be completed due to lack of lot information from the user facility.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.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The device is packaged with instructions for use, which state, "upon removal from the package, inspect the product to ensure no damage has occurred." based on the available information, cook has concluded that a cause for the event could not be determined.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.

Event Description

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

• 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: 10595820
• MDR Text Key: 208955970
• Report Number: 1820334-2020-01763
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-CHSG-703001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1