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This is a spontaneous case report received from a health professional in (b)(6) on 16-mar-2015 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted.The device did not release the correct way at time of insertion.The patient is ok.Follow-up information received on 13-may-2015 from physician.Additional information received on 15-may-2015: product technical complaint (ptc) investigation.This case refers to a (b)(6) female patient.On (b)(6) 2015, essure lot number c38215 was inserted.According to the physician, as inserting after pressing the release button the implant did not come loose.When the catheter was withdrawn the inner coil was extended.Essure was not removed.Patient had no injury and she was recovered from the event.Physician stated the event could not have led to serious injury under less fortunate circumstances.Reported also provided (b)(6) 2015 as event date (discrepancy).Initial product technical complaint investigation (updated analysis with the provided lot number was requested): this adverse event report is related to a product technical complaint and was initiated due to a request for confirmation of quality.(b)(4).Final assessment: the complainant describes an event where there was difficulty getting the insert to release from the catheter.Several factors can contribute to a detachment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the insert's grip on the delivery wire, and potential manufacturing deficiencies.As of may 12, 2015, 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.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.The possibility of a detachment difficulty event during the procedure is an anticipated event.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The ae case refers to a usability issue.No adverse events were reported at this point in time.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.Neither batch number nor complaint sample were available for a technical investigation at this point in time.The technical investigation concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up information received on 18-may-2015.Additional information (updated ptc results) received on 21-may-2015: the (b)(6) health authority informed that the medical products agency has analysed the information given to them and have decided to close the file on this case.No clinical new information was received from the health authority.Ptc results were updated based on the reported lot number c38215 and on the sample received at manufacturer.(b)(4).Final assessment: detachment difficulty is defined as a failure of the micro-insert to detach (separate) from the delivery system.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper detachment: rollback to initial hard stop; depress button; perform final rollback.Under normal circumstances, when the physician completes all deployment steps as outlined in the ifu, the micro-insert assembly will detach from the delivery wire and remain in the fallopian tube.Several factors can contribute to a detachment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the insert's grip on the delivery wire, and potential manufacturing deficiencies.Since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint.We typically inspect the micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly.The device was received without micro-insert.All ifu steps were completed.The catheter large tight pitch coil found to be stretched and broken.We were unable to confirm any quality defect or device malfunction at this time.We also 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.The possibility of a detachment difficulty event during the procedure is an anticipated event.Medical assessment: this ptc was initiated due to a product technical issue.However, no adverse events have been reported.The batch documentation of the reported batch was reviewed.The returned complaint sample was investigated.The technical investigation concluded unconfirmed quality defect.Since no adverse events have been reported, a batch investigation with respect to similar ae cases is not applicable.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Case considered other reportable incident.The list of similar cases contains essure reports received by bayer with similar events coded in meddra.In this particular case a search in the database was performed on 27-may-2015 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1006 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Company causality comment: this medically confirmed, spontaneous case report refers to a 38 year-old female patient who had essure (fallopian tube occlusion insert) inserted and during the procedure the device did not release the correct way; when physician removed the catheter the inner coil was extended; essure insert was left in place and patient had no injury.All the events were considered non-serious and are listed in the reference safety information for essure.In this particular case, a product technical analysis (ptc) was performed with analysis of the complaint sample (which included the device without the micro-insert).At complaint sample inspection the catheter large tight pitch coil was found to be stretched and broken.The ptc analysis concluded that the reported detachment difficulty event during the procedure is an anticipated event and considered there is no reason to suspect a causal relationship to a potential quality deficit based on this report.This case was initially regarded as non-incident.However, upon receipt of complaint sample analysis (which revealed a device breakage), it was amended to other reportable incident; as although patient had no serious injury this might have occurred under less fortunate circumstances.No further information is expected.
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