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

Catalog Number FTC-550-NT

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The distributor reported during a fallopian tube recanalization procedure on (b)(6) 2017, the fallopian tube catheterization set was used.As reported, recently the doctor reviewed the patient report and found that the black tip of the inner catheter was broken and remained inside the patient¿s left uterine corner.As reported, a section of the device remains inside the patient¿s body.The patient has been discharged.Still keeping eyes on this matter.No emergency measures have been taken yet.The distributor reports the hospital refuses to provide any additional information.

Manufacturer Narrative

Additional information: patient code: no code available for additional intervention is labeled.Additional information was received on 02nov2017, the patient was diagnosed with bilateral fallopian tube obstruction.During the interventional re-canalization the right side was operated on first followed by the left side.During the procedure, the j-tipped wire guide along the outer (delivery) catheter was introduced in the patient¿s body after finding the opening of the fallopian tube site, then the j type wire guide was removed.Then the combination of the inner wire guide and inner catheter was introduced through the outer catheter already in place.The distal end of the wire-guide was slightly beyond the distal tip of the inner catheter.The outer catheter was inserted into the opening of the fallopian tube, the inner catheter is inserted into the interstitial part, and the inner wire guide is inserted into the proximal part of the isthmus.The mixture of contrast agent along with dexamethasone was injected into the patient.The uterus of the patient deviated to the right, was anteverted and anteflexed (the uterus leans forwards over the top of the bladder).The insertion in the right fallopian tube was smooth but it was difficult to insert into the left fallopian tube.The separated portion of the black tip of the inner catheter remains in the left side of the uterus horn.No additional measures have been carried out since.It is also reported that the patient is pregnant (self-test).Investigation ¿ evaluation: investigation of this complaint included a review of the device history record, patient imaging, drawings, instructions for use, manufacturing instructions, quality control data and an inspection of returned unused product.The device history record for the complaint lot number was reviewed and no non-conformances were noted.The device history record for one of the component lot numbers was also reviewed and no nonconformance¿s were noted.The device history record for the second component lot number was also reviewed and noted five non-conformances.The non-conformances noted include: bond, flaps outside, outside fiber, bond, pitted, bond, dirty and bond, bent.The complaint device was not returned for evaluation but a fluoroscopic image was provided by the facility.Twelve (12) unused devices from the complaint lot have returned to aid the investigation.Based on the image review it is uncertain whether the microcatheter fractured or not due to the poor quality of the image.Unless there was a manufacturing defect, the only foreseeable way of sheering off the tip of the microcatheter would be to retract the microcatheter into the outer catheter at an area of acute angulation.Testing was performed on one of the returned unopened devices.A 0.018" wire guide was inserted into the lumen of the inner catheter.The device was then flexed at approximately 45 degrees at the shaft to bond connection.The tip of the device separated into two portions.A portion of the tip was still attached to the catheter.After the destructive testing, the separation site was uneven/jagged with two small cracks in the proximal portion.Testing on the remaining eleven devices will be performed under the root cause investigation phase of the capa process following the approval of a formal testing protocol.A review of complaint history for this device/lot combination revealed this to be one of seven reported complaints associated to this complaint lot number and the two component lots for issue of the black tip of the inner catheter breaking off.All seven of these complaints are from the same customer, occurred in the same facility and all of the procedures were performed by the same doctor.Based on the available information and examination of the unused device, the exact cause of the reported issue has not yet been determined.However, it is possible that the environmental conditions the complaint devices were exposed to during shipping, transportation, storage, etc.Could have caused degradation of the tip material and/or that the doctor performed a tubal recanalization which is off-label use.The instructions for use (ifu), states that the intended use of the device is for selective catheterization of the proximal fallopian tube(s), injection of contrast medium, and evaluation of tubal patency.The ifu also states that the "fallopian tube catheterization sets are not intended for complete catheterization of the fallopian tube or tubal recanalization.There is no data available showing any clinical benefit for use in this manner.".In accordance with cook¿s complaint handling procedure, there is active ongoing communication with cook field representatives attempting to obtain additional information regarding this event.Cook is seeking clarification regarding patient outcomes, product storage conditions, and further complaint details.Based on the available information and without the benefit of a returned complaint device, a definitive root cause cannot be determined for this occurrence.However, it is possible that the user did not follow the operating instructions given in the device ifu as well as the device was not stored/shipped properly.Further steps have been initiated to address this issue.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: FALLOPIAN TUBE CATHETERIZATION SET
• Type of Device: LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6865291
• MDR Text Key: 86146003
• Report Number: 1820334-2017-02966
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 00827002109926
• UDI-Public: (01)00827002109926(17)180130(10)5569142
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K955508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: FTC-550-NT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 12/07/2017
• Date Device Manufactured: 01/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR