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| Model Number ESS305 |
| Device Problem
Failure to Unfold or Unwrap (1669)
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| Patient Problem
Foreign Body In Patient (2687)
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Event Type
malfunction
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Event Description
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This is a spontaneous case report received from a physician in united states on (b)(6) 2014 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted.Physician reported that a patient was having an essure placed on (b)(6) 2014 (lot number not provided) and it failed to unfoil.The physician could not remove it from the left fallopian tube.The right side was placed fine.The procedure was videotaped and was on cd.No additional information was provided.Follow-up information was received on (b)(6) 2014: patient's initials and date of birth were provided.This report refers to a (b)(6) years old female patient.She was not pregnant.On (b)(6) 2014 the physician stated that she inserted essure into right tube which was the more difficult tube due to location and some blood clots but it was placed successfully.When she was inserting the essure (lot number c80063) into left tube and she tried roll back it would not roll back and it made a noise but did not click in tube.She pulled the coil out but something began to uncoil, unravel so that it was uncoiled from the tube to outside the patient's body.Some of the coil was still in the patient's left tube.An x-ray was not done.Unit was available for return.No further information was provided.Fup information was received on (b)(6) 2014: the physician said that during the procedure the inserter did not deploy correctly.She pushed the button and was unable to do the roll back.She removed the inserter, but this stretched out.She then went back in and it looked like a few cm of inserter coil were left in the patient.She also thought she saw a piece of the green sheathing.The physician would like to know if she should cut this and what to use to cut it.An x-ray was not performed but the physician believed the insert was in the patient.The inserter was checked with the sc and it was not attached.The physician did attempt to remove the few cm of inserter coil but it would not detach.A tubal ligation was planned.The patient wanted an ablation and did not want to wait for the hysterosalpingography in 3 months.So physician decided for a tubal ligation.Physician does not believe insert has perforated.Follow-up received on (b)(6) 2014: information received from physician states that, on (b)(6) 2014, device on left tube failed to deploy.Health care professional also informed that a part of device has been left in the patient's tube.No injury occurred and bilateral placement was achieved.Fup information was received on (b)(6) and (b)(6) 2014 from physician.In addition on (b)(6) 2014 the ptc final assessment was received.The physician confirmed the demographic information from the patient.The physician stated that on (b)(6) 2014 the essure was inserted, lot number c80063, but the deployment of device on the left tube failed.And a part of device has been left in the tube of patient.In addition the physician considered that bilateral placement was achieved.These events reported were related to a product technical complaint (ptc).The bayer reference number for the ptc report: (b)(4) and us(b)(4).Final assessment: the production date for lot c80063 is (b)(6) 2014.Rollback difficulty is defined as an event in which either the user is (1) unable to perform initial rollback of the thumbwheel due to very high resistance, or (2) able to perform initial rollback of the thumbwheel, but the activity is difficult due to higher than expected level of resistance.Several factors can contribute to a rollback difficulty event.The most likely root causes are a defective thumb wheel or defective catheter rack which prevents the rollback mechanism, inadvertent closure of a hysteroscope valve during the placement procedure which binds up the catheter components and prevents rollback movement, excessive solder material which could prevent components from sliding past each other, a damaged micro-insert which could bind the micro-insert to the outer catheter and prevent catheter movement, or tubal spasms which bind catheter components and temporarily restrict the movement of catheter components.In this case, no spontaneous breakage was reported.The physician pulled the coil out to resolve the rollback issue.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 thumbwheel teeth, rack teeth, delivery wire to delivery wire holder solder bond, hypo-tube to handle solder bond, micro-insert condition, and condition of the outer catheter 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.We are unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time per criteria established in (b)(4), processing essure cases in (b)(4), because this is an anticipated failure mode.The risk to the patient for this failure mode was assessed during the design process, and adequate risk mitigation actions were taken to minimize the residual risk as documented in (b)(4), design (b)(4) for (b)(4).Medical assessment: this ptc was initiated due to a reported product quality issue and usability issues.No adverse events were reported at this point in time.No complaint sample was provide for further investigation.The technical assessment concluded unconfirmed quality defect.No batch signal review for similar ae case reports for batch no.(b)(4) (production date (b)(6) 2014; expiration date 31-jul-2017) could be conducted as no adverse vents were reported.No batch signal could be identified.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.The reported usability issues will be subject to post market surveillance monitoring.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) year-old female patient who had essure (fallopian tube occlusion insert) inserted and some of the coil was still in the patient's left tube, piece of the green sheathing in the patient.This event, interpreted as device breakage, is non-serious and unlisted according to the reference safety information for essure.In this particular case, the physician reported that she was inserting the essure into left tube and the inserter did not deploy correctly (failed to unfoil).She pushed the button and was unable to do the roll back.She removed the inserter, but this stretched out.She then went back in and it looked like a few centimeters of inserter coil were left in the patient.She also thought she saw a piece of the green sheathing.The right side insertion was difficult but device was placed correctly.Based on the information received, and given the nature of the reported event a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident due to the reported breakage.Physician decided for a tubal ligation.Physician does not believe insert has perforated.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.The reported usability issues will be subject to post market surveillance monitoring.No further information is expected.
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Manufacturer Narrative
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Follow up information received on 15-oct-2014 from physician: patient`s weight and height were added.Patient did not have any gynecological problems or procedures.The patient was not on post-partum state at time of insertion.The essure lot number used was c80063; per reporter no udi number was available.During the insertion, cervical dilatation and sounding were done.A cervical block was used as analgesia, no general anesthesia was used.The insertion was considered easy; with easy visualization of the tubal ostuim.No fluid loss of more than 1500cc was observed; and did not take more than 20 minutes.The patient used depo provera as back-up contraception.No imaging tests were done to confirm essure placement; per reporter she was not at the 3 months procedure.Physician confirmed the events previously reported.No treatment and no diagnostics tests were used or performed.The events occurred on (b)(6) 2014.Physician also reported that the essure devices caused or contributed to the patient`s condition due to applicator failure, it was unable to roll back the wheel and the device deployed in patient`s tube.At time of the report, essure were not removed.They were awaiting the hsg (hysterosalpingogram) prior to plan the removal; patient declined surgical intervention, she wanted to wait the hsg to assess tubal patency.No further information was provided.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) year-old female patient who had essure (fallopian tube occlusion insert) inserted and some of the coil was still in the patient's left tube, piece of the green sheathing in the patient.This event, interpreted as device breakage, is non-serious and unlisted according to the reference safety information for essure.In this particular case, the physician reported that she was inserting the essure into left tube and the inserter did not deploy correctly (failed to unfoil).She pushed the button and was unable to do the roll back.She removed the inserter, but this stretched out.She then went back in and it looked like a few centimeters of inserter coil were left in the patient.She also thought she saw a piece of the green sheathing.The right side insertion was difficult but device was placed correctly.Based on the information received, and given the nature of the reported event a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident due to the reported breakage.Physician decided for a tubal ligation.Physician does not believe insert has perforated and she is waiting the hysterosalpingogram to decide about a possible removal.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.The reported usability issues will be subject to post market surveillance monitoring.No further information is expected.
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Manufacturer Narrative
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Follow up received on 09-dec-2014 from physician: on unspecified date, the patient had a bilateral tubal ligation and an ablation done.At time of the report she was doing well.Physician stated that bilateral essure devices were in tubes in appropriate position.No further information was provided.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and some of the coil was still in the patient's left tube, piece of the green sheathing in the patient.This event, interpreted as device breakage, is non-serious and was 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.In this particular case, the physician reported that she was inserting the essure into left tube and the inserter did not deploy correctly (failed to unfold).She pushed the button and was unable to do the roll back.She removed the inserter, but this stretched out.She then went back in and it looked like a few centimeters of inserter coil were left in the patient.She also thought she saw a piece of the green sheathing.The right side insertion was difficult but device was placed correctly.Patient underwent a bilateral tubal ligation and an ablation was performed.Based on the information received, and given the nature of the reported event a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident due to the reported breakage.Physician does not believe insert has perforated and she is waiting the hysterosalpingogram to decide about a possible removal.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.The reported usability issues will be subject to post market surveillance monitoring.No further information is expected.
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Search Alerts/Recalls
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