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 Deflation Problem (1149)

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

Event Date 10/16/2019

Event Type  malfunction  

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 was reported, prior to use on a patient, a cook silicone balloon hysterosalpingography injection catheter was tested, and the balloon did not deflate when air was extracted using the provided syringe.No known 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.

Event Description

No new patient or event information since the last report was submitted on 28oct2019.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable investigation - evaluation.Reviews of instructions for use (ifu), manufacturing instructions, 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 review 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: warnings "always inflate the balloon with a sterile liquid.Never inflate with air, carbon dioxide or any other gas." precautions "do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture." how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." the complainant did not return the complaint device to cook for investigation.Because production lot information was not provided, no representative product from the production lot could be evaluated.The complaint was confirmed based on the customer¿s testimony.The most likely cause of the issue was determined to be the user's failure to follow instructions.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.

Event Description

The device lot number was provided on (b)(6) 2019.The lot number information was inadvertently not reported on the initial or follow up mdr reports.There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable corrected information: d4: lot number, expiration date, and unique identifier (udi), and h4.Additional information: h6: method code description 1 and 2 and h10: - investigation evaluation.It was reported, a cook silicone balloon hysterosalpingography injection catheter was tested by being inflated with air prior to use.The operator found that the balloon could not be deflated using the provided syringe.The device was not used in a procedure, and no adverse events were reported.Investigation - evaluation reviews of complaint history, and device history record(dhr) were conducted during the investigation.A review of the device history record found four non-conformances related to fitting, damaged.We were unable to determine if these failure modes are related to this incident.A review of complaint history records shows one other complaint associated with the complaint device lot.Issue for this other complaint was balloon did not inflate.Due to the individual nature of the manufacturing and inspection process for the devices in the lots, it is unlikely that these events are an indication of device issue within the entire lot.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: 9246095
• MDR Text Key: 174305940
• Report Number: 1820334-2019-02703
• 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,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2020
• Device Catalogue Number: J-CHSG-503000
• Device Lot Number: 8446248
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1