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	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #- k180291.Device evaluated by mfg - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during attempted inflation of a cook silicone balloon hysterosalpingography injection catheter, the device was observed to be occluded.This was discovered prior to patient contact.The procedure was completed using another device.No adverse effects to the patient were reported as a result of this occurrence.Upon return evaluation of the device 13may2021, the balloon was ruptured.
Additional Manufacturer Narrative
Event summary: as reported, during attempted inflation of a cook silicone balloon hysterosalpingography injection catheter, the device was observed to be occluded.This was discovered prior to patient contact.The procedure was completed using another device.No adverse effects to the patient were reported as a result of 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 cook silicone balloon hsg catheter was returned for investigation.Visual examination confirmed that the balloon was returned burst and therefore could not be tested for an occlusion.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.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.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 device is provided with instructions for use which state, "upon removal from the package, inspect the product to ensure no damage has occurred." based on the available information, cook has concluded that a cause for this event could not be determined.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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
• MDR Report Key: 11982859
• Report Number: 1820334-2021-01500
• Device Sequence Number: 3560810
• Product Code: LKF
• UDI-Device Identifier: 00827002178700
• UDI-Public: (01)00827002178700(17)230420(10)13143075
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 04/20/2023
• Device Model Number: G17870
• Device Catalogue Number: J-CHSG-703000
• Device Lot Number: 13143075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 50