MAUDE Adverse Event Report: COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER; LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	G17870
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the operator checked the cook silicone balloon hysterosalpingography injection catheter prior to use and found the balloon ruptured.The procedure was completed by using another new device.No adverse effect to the patient was reported.
Additional Manufacturer Narrative
Pma/510k # k180291.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Correction- b1, h1: no reportable device malfunction occurred.A detailed search using the validated business objects report, qe15- complaint investigation- sales and complaint history, revealed that there have been no deaths or serious injuries per 21 cfr part 803.3, due to a (j-chsg) silicone balloon hsg catheter balloon bursts or leaks during or prior to the procedure from (b)(6) 2019 through (b)(6) 2022.The most recent event where a silicone balloon hsg catheter balloon burst or leaked and resulted in a serious injury, per 21 cfr part 803.3, occurred on (b)(6) 2019.Since then, all mdr¿s submitted from 15oct2019 through 13jan2022 for (j-chsg) silicone balloon hsg catheter balloon bursts or leaks during or prior to the procedure have been malfunction reports.An mdr guidance for manufacturers issued in 1997 stated that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established.This presumption will continue until either the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show through valid data that the likelihood of another death or serious injury as a result of the malfunction is remote.Therefore, base on current information, this event is not reportable.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 or Problem Description
There is no new patient or event information to report.

• Brand Name: COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
• Common Device Name: LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12962801
• Report Number: 1820334-2021-02650
• Device Sequence Number: 1854711
• Product Code: LKF
• UDI-Device Identifier: 00827002178700
• UDI-Public: (01)00827002178700(17)240609(10)14014633
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2024
• Device Model Number: G17870
• Device Catalogue Number: J-CHSG-703000
• Device Lot Number: 14014633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female