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

Model Number G17870

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2019

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 is reported during a sonohysterosalpingography, in vagina cervix and uterus using a cook silicone balloon hysterosalpingography injection catheter, the balloon was impossible to deflate when the procedure was over.It is unknown how the procedure was completed after this issue was experienced.There were no adverse effects to the patient as a result of this alleged product malfunction.No section of the device remained inside the patient's body.The patient did not require any additional procedures 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

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Investigation ¿ evaluation.The complaint device was not returned, therefore visual examination and functional testing could not be performed.A document based investigation was performed including a review of complaint history, device history record, specifications, device history record, manufacturing instructions, trends, and quality control data.Although the initial complaint stated that the complaint device was to be returned, the complainant did not return the complaint device to cook for investigation.Cook has made multiple attempts to reach out to complainant for return information, without response.If the device is return to cook for evaluation, the investigation will be updated.A review of the device history record did not observe any nonconformances that may have contributed to this incident.A review of complaint history revealed this complaint to be 1 of 3 complaints from this facility associated with reported complaint lot number.The investigation found no indication that a design or process related failure mode contributed to this event.While, the complainant did not return this complaint device to cook for investigation, cook has received a complaint for the same product experiencing the same deflation failure mode.The physical examination of the complaint device in that case found that the balloon inflated and deflated without issue.The investigation for that complaint concluded that the cause of the complainant's difficulty was unknown.Because of the similarities between the referenced complaint and the current complaint, it is possible that evaluation of the current complaint device would reach a similar conclusion.Conclusion: cook has concluded a definitive cause 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 at this time the appropriate internal personnel have been notified and we will continue to monitor 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.

• 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: 8627710
• MDR Text Key: 145639022
• Report Number: 1820334-2019-01163
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002178700
• UDI-Public: (01)00827002178700(17)210126(10)8539787
• 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: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2021
• Device Model Number: G17870
• Device Catalogue Number: J-CHSG-703000
• Device Lot Number: 8539787
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1