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

Model Number	G17147
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address- phone: (b)(6).Occupation- head of regulatory affairs.Pma/510(k) #- k180291 event summary: as reported, a cook silicone balloon hysterosalpingography injection catheter would not inflate when tested prior to use in a sonohysterography.The balloon was attempted to be inflated with water with the provided syringe.A new balloon 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.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.One open package containing a cook silicone balloon catheter was returned for investigation in a used condition.The catheter length measures 31cm and was bent approximately 15cm from the distal tip.The balloon was ruptured, preventing inflation.A document-based investigation evaluation was performed.No related non-conformances were recorded.One additional complaint was received for this product lot describing the same failure mode.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 device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.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 device is included with instructions for use which caution, ¿do not over inflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.Refer to product label or the inflation check valve on the balloon device for appropriate balloon volume.¿ based on the available information, cook has concluded that unintended user error contributed to this incident.Cook will continue monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
As reported, a cook silicone balloon hysterosalpingography injection catheter would not inflate when tested prior to use in a sonohysterography.The balloon was attempted to be inflated with water with the provided syringe.A new balloon 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.

• 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
• MDR Report Key: 11692525
• Report Number: 1820334-2021-01166
• Device Sequence Number: 2980760
• Product Code: LKF
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)220320(10)9607640
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

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: 03/20/2022
• Device Model Number: G17147
• Device Catalogue Number: J-CHSG-503000
• Device Lot Number: 9607640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/20/2021
• Patient Sequence Number: 1