MAUDE Adverse Event Report: COOK INC SELECTIVE SALPINGOGRAPHY CATHETER; LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	G17359
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #- k181770.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 an unspecified procedure using a selective salpingography catheter, the operator opened the pouch and found the device was "broken." an image of the device was provided showing the device had separated.The procedure was completed using a new device.The issue with this device was discovered prior to making contact with the patient and it was not used.No adverse events have been reported as a result of the alleged malfunction.The patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, during an unspecified procedure using a selective salpingography catheter, the operator opened the pouch and found the device was "broken." an image of the device was provided showing the device had separated.The procedure was completed using a new device.The issue with this device was discovered prior to making contact with the patient and it was not used.No adverse events have been reported as a result of the alleged malfunction.The patient did not require any additional procedures due to this occurrence.Investigation - evaluation.Reviews of the complaint history, device history record, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.Accordingly, no physical examination was performed.A photograph was provided which showed the device was separated.A document-based investigation evaluation was performed.No related non-conformances were recorded, and no additional lot-related complaints were received.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.Based on the available information, cook has concluded that the most probable cause of the 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: SELECTIVE SALPINGOGRAPHY CATHETER
• Common Device Name: LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11520129
• Report Number: 1820334-2021-00972
• Device Sequence Number: 3430419
• Product Code: LKF
• UDI-Device Identifier: 00827002173590
• UDI-Public: (01)00827002173590(17)211121(10)9328118
• 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,Followup
• Report Date (Section B): 05/18/2021

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: 11/21/2021
• Device Model Number: G17359
• Device Catalogue Number: J-SSG-554086
• Device Lot Number: 9328118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1