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

Model Number	G17472
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a sonohysterography, a cook silicone balloon hysterosalpingography injection catheter was difficult to deflate.The device was used after an initial catheter was difficult to inflate.The second device was tested outside of the patient and inflated to the maximum fill volume as per the device instructions using saline or water.The balloon was eventually able to be deflated, and a third catheter was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(6).Pma/510(k) #- k180291.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during a sonohysterography, a cook silicone balloon hysterosalpingography injection catheter was difficult to deflate.The device was used after an initial catheter was difficult to inflate.The second device was tested outside of the patient and inflated to the maximum fill volume as per the device instructions using saline or water.The balloon was eventually able to be deflated, and a third catheter was used to complete the procedure.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, the instructions for use, and quality control data.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 made out of specification.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed.One other lot related complaint has been received from the field.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.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." cook has concluded a definitive cause could not be determined from the available information.Per the quality engineering risk assessment, no further action is warranted.Cook 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.
Additional Manufacturer Narrative
Correction: this report is being sent to indicate the complaint event is not reportable under fda 21 cfr part 803.Upon further investigation, this event is not reportable.This event does not meet the criteria for a serious injury.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.A detailed review of complaint history using a validated report revealed that there have been no deaths or serious injuries, per 21 cfr part 803.3, due to difficult inflation/deflation of the balloon of a silicone uterine balloon from (b)(6) 2019 through (b)(6) 2022.Therefore, cook will cease malfunction reporting for events involving difficult inflation/deflation of the balloon of a silicone uterine balloon.The recurrence of a serious injury or death for the same malfunction will trigger the resumption of mandatory reporting, per 21 cfr part 803.50.As such, this event no longer meets the set criteria for a reportable event; no further reports regarding this event will be submitted.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 12760137
• Report Number: 1820334-2021-02447
• Device Sequence Number: 16930125
• Product Code: LKF
• UDI-Device Identifier: 00827002174726
• UDI-Public: (01)00827002174726(17)220513(10)9734605
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2022

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: 05/13/2022
• Device Model Number: G17472
• Device Catalogue Number: J-CHSG-503001
• Device Lot Number: 9734605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 11/09/2021; 02/16/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 11/29/2021; 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• 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