MAUDE Adverse Event Report: COOK INC FALLOPIAN TUBE CATHETERIZATION SET; LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	G04324
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported, during a fallopian tube cannulation procedure, using a fallopian tube catheterization set, a section of the catheter broke inside the patient while removing the device.The operator immediately retrieved the broken section under hysteroscope.No section of the device remained inside the patient.No adverse events have been reported as a result of the alleged malfunction.
Additional Manufacturer Narrative
Event summary: it was reported, during a fallopian tube cannulation procedure, using a fallopian tube catheterization set, a section of the catheter broke inside the patient while removing the device.The operator immediately retrieved the broken section under hysteroscope.No section of the device remained inside the patient.No adverse events have been reported as a result of the alleged malfunction.Investigation - evaluation.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures and a visual inspection, dimensional verification, and functional test of the device were conducted during the investigation.One 3fr catheter was returned or investigation.Physical examination of the returned device showed the device was separated in two pieces.The proximal section measured 50.1cm, and the distal section measured 15cm.The catheter was jagged and smashed at the separation point.The catheter shaft was damaged/smashed/wavy/elongated throughout both the proximal and distal sections.The outer diameter of the catheter shaft was measured to be within specification.The tip was not separated.The end hole was slightly out of round but not damaged.A document-based investigation evaluation was performed.No related non-conformances were found, and no other lot-related complaints have been 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.There were no identified gaps in the device manufacturing instructions, specifications, or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use which warn, ¿if significant resistance is felt, do not attempt to advance the catheter,¿ and, ¿do not attempt to advance the catheter or mandril wire guide beyond the tubal isthmus.¿ based on the information available, cook has concluded that this event can be traced to a component failure without manufacturing or design deficiency.It is possible that tortuous anatomy could have contributed to this failure.We will continue our monitoring of similar complaints and have 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: FALLOPIAN TUBE CATHETERIZATION SET
• Common Device Name: LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10283539
• Report Number: 1820334-2020-01306
• Device Sequence Number: 19005243
• Product Code: LKF
• UDI-Device Identifier: 00827002043244
• UDI-Public: (01)00827002043244(17)220815(10)9861313
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K171604
• Number of Events Summarized: 1
• Summary Report (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): 09/09/2020

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: 08/15/2022
• Device Model Number: G04324
• Device Catalogue Number: FTC-900
• Device Lot Number: 9861313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 52