|
This is a spontaneous case report received from another (hospital's assistant buyer) in united states on (b)(6) 2014 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2014, lot number c06468.In (b)(6) 2014 during the insertion procedure, the spring would not detach and broke before deployment.There was no patient injury.The reporter is requesting essure replacement.No other information was provided and no assessment was given by the reporter.Ptc investigation result was received on (b)(4) 2014.This adverse event report is related to a product technical complaint (ptc).(b)(4).Final assessment: when a term like "broke before deployment" is used when describing a device event, it is difficult to determine the true nature of the event from the complaint description alone.Unless additional detail is provided in the event description, it is difficult to determine if the reporter is describing an event where the micro-insert actually broke into individual pieces, if the microinsert bent or stretched into an unintended shape, and hence was considered by the reporter to be "broken", or if a different portion of the delivery catheter was broken off inside the patient.Failure mode/mechanism: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The insert's outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth.After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function.If the outer coils of the micro-insert partially deploy during user attempts to repositioning the device and the coil catheter is not fully retracted, the outer coils of the micro-insert could become entangled within the distal portion of the coil catheter.If the outer coils are partially deployed, the insert will begin to anchor itself to the fallopian tube.If the inner coil is still affixed to the delivery wire because all ifu steps have not yet been completed, subsequent attempts by the user to remove the catheter assembly may lead to either a stretching of the micro-insert, stretching of the inner catheter large tight pitch coil, or breakage of the large tight pitch coil.If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert.Since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert, the outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all are within manufacturing specifications.In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.Since neither product was returned for inspection nor do we have a photograph of the actual device, we cannot determine exactly what the failure is.Since no product was returned for investigation, we are unable to confirm any quality defect or device malfunction at this time.Conclusions: the possibility of pieces of the delivery system or micro-insert breaking off during the procedure is an anticipated event.According to the dfmea, the main consequence is a physician inconvenience because the procedure could need to be aborted or rescheduled.Medical assessment: this ptc was initiated due to a reported product issue.The ae case refers also to usability issues.However, no adverse events have been reported at this point in time.No complaint sample was provided for further technical investigation.The batch documentation was reviewed.The technical assessment concluded "unconfirmed quality defect".Since no adverse events were reported, no batch signal review for similar adverse events could be conducted.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.The reported usability issue will be subject to post market surveillance monitoring.Lot number c06468 (production date 18-dec-2013 and expiration date 31-dec-2016).Company causality comment: this medically confirmed and spontaneous case report refers to a female patient who had an attempt of essure (fallopian tube occlusion insert) insertion and, during insertion procedure, spring would not detach and broke before deployment (complication of device insertion/failed insertion).The reported events, interpreted as a device deployment issue and breakage are non-serious.Device breakage during insertion, previously regarded as unlisted according to the reference safety information for essure; however upon receipt of the product technical analysis (ptc), which stated that micro-insert breaking off during the procedure is an anticipated event; it was amended to listed.Also, the remaining event is listed.Single cases of essure breakage have been reported.In this particular case, the reporter stated that spring would not detach and broke before deployment.Reporter is requesting essure replacement and sample is available for return.Based on the information received, and given the nature of the reported events, a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident due to the reported breakage.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.No further information is expected.
|
|
Information received from consumer states that only half of the device was defective.Sales representative provided patient's initials and date of birth ((b)(6) at time of event).The essure procedure date was (b)(6)2014.No further information was provided.Follow up information received on (b)(6) 2014 from physician: the patient had significant menorrhagia as concomitant condition; and also needed permanent sterilization.On (b)(6) 2014, the operative course was: after induction of general anesthesia, patient was prepped in usual manner.Bladder was catheterized.Cervix grasped with tenaculum and the cervix dilated.Hysteroscope placed with both tubal ostia seen.The initial essure placed on the right side.It did not deploy properly and was removed.The left-sided essure device was placed with 3 coils within the endometrial cavity.He returned to the right side, where a new essure coil was placed without difficulty with 4 coils within the endometrial cavity.Mirena iud was then placed in the uterine cavity with strings trimmed to 2.5 cm and the procedure terminated.The bleeding was minimal.Patient left the operating room in stable condition.Physician stated that after essure problems he removed the device from the inserter, removed the inserter from the scope and reinserted the scope and placed new devices in each tube without incident.There was no breakage.The essure 305 started to deploy but did not detach from the inserter and was removed.The operative findings were symmetric uterus and thin endometrial lining.There were no complications during the procedure.Company causality comment: this medically confirmed and spontaneous case report refers to a (b)(6) female patient who had an attempt of essure (fallopian tube occlusion insert) insertion and, during the procedure, spring would not detach (complication of device insertion).The patient had mirena (levonorgestrel) inserted (off label use) on the same time and there was minimal bleeding.The first event, interpreted as device deployment issue, is non-serious, while the remaining event, seen as procedural bleeding, is serious due medical importance.Both events are listed in the reference safety information for essure and for mirena.In this particular case, the right essure micro-insert did not deploy properly and was removed.The left-sided essure device was well placed.He returned to the right side, where a new essure coil was inserted without difficulty.Then, mirena iud was placed in the uterine cavity (off label use) and the procedure terminated.The bleeding was minimal.Patient left the operating room in stable condition.Considering the deployment issue has occurred during essure micro-insert placement, a causal relationship with essure cannot be excluded and since it was before mirena insertion, causality with the ius is considered as unrelated.The nature and circumstances of bleeding were not informed, so it is not known if it was the mirena placement or the essure insertion that caused the event, therefore it is assessed as related to essure and mirena.Initially, device breakage was also reported and the case was assessed as other reportable incident.Upon receipt of follow up information the event was updated to device deployment issue only and the case was therefore downgraded to non-incident.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.An updated technical analysis is expected.
|
