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 Discomfort (2330)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: sterile technician.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, the doctor had completed a sonohysterogram using a cook silicone balloon hysterosalpinography injection catheter, and when he attempted to deflate the device he found that the balloon tip would not deflate.The doctor had to pull the catheter out fully inflated.No unintended section of the device remained inside the patient.The patient was reported to be "fine", she just experienced discomfort during the procedure.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Ec method code desc - 5: communication/interviews (4111).Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.Visual examination of the returned device noted the catheter was bent 1.5cm and 19.5cm from the distal tip the balloon deflated, but pressure was needed when depressing the plunger.Functional testing determined the balloon inflated properly.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows one other complaint associated with the complaint device lot.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.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." instructions for using cook silicone balloon hsg catheter saline infusion sonohysterography 6.Fill the syringe with sterile saline solution.Eliminate air from the syringe.7.To inflate the balloon, instill sterile saline solution." how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded the operator's failure to follow instructions contributed to this incident.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.

• 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: 9535725
• MDR Text Key: 176051914
• Report Number: 1820334-2019-03167
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)211130(10)9347392
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: G17147
• Device Catalogue Number: J-CHSG-503000
• Device Lot Number: 9347392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1