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 Type  malfunction  

Manufacturer Narrative

(b)(6).A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during a uterine cavity procedure using a cook silicone balloon hysterosalpingography injection catheter, the balloon burst.The doctor was attempting to inflate the balloon with 1.5 ml of nacl (sodium chloride), but the balloon burst when it was filled with only 1.4 ml nacl.The procedure was completed when they "took another hsg catheter".No adverse events have been reported due to the alleged malfunction.Additional details have been requested regarding the patient and event.At this time no additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable investigation - evaluation reviews of instructions for use (ifu), trends, and quality control data 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 could not be completed due to lack of lot information from the user facility.A search for other complaints associated with the complaint device lot number could not be completed due to lack of lot information from the user facility.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." how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." no device was returned for evaluation.There is no indication that a design related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The complaint was confirmed based on customer testimony.A definitive root cause of the events could not be determined.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue to monitor for similar complaints.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

Additional information was received (b)(6) 2019: it was reported, the procedure being performed was a hysterosalpingogram (hsg).There was no harm to the patient.The device was tested prior to placement and the balloon burst during the test.A new catheter was used to complete the procedure.

• 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: 9272338
• MDR Text Key: 165398170
• Report Number: 1820334-2019-02759
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• 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: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1