MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

Model Number ESS305

Device Problems Break (1069); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problems Complaint, Ill-Defined (2331); Insufficient Information (4580)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a physician in (b)(6) on (b)(6) 2014 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted and experienced bad device release on the left.Device remained attached to the introducer, the coil stretched until breakage, and the coil was cut flush to the left ostium, and bilateral placement was not performed.No info given on patient's history, past drugs and concurrent conditions.It is not reported whether the patient received any concomitant medication.On (b)(6) 2014 the patient had essure (fallopian tube occlusion insert) inserted at operating room, lot number b40025, at unk.During placement, bad device release was observed on the left, device remained attached to the introducer.The coil stretched until breakage.The device could not be pulled out, distended as a result of pulling, small pieces were withdrawn successively.For the remaining part of device still in tube, the coil was cut flush to left ostium.No anatomic reason could explain the anomaly.Procedure on the right was uneventful, 3 trailing coils.Bilateral placement was not performed.Medical device vigilance procedure was done within the hospital, no declaration to health authorities in (b)(6).The device was kept in the hospital.No other info available.

Manufacturer Narrative

Follow-up information received on 23-apr-2014 - ptc investigation result provided: ptc global number: 2014-007571.Medical assessment: this case refers to the technical event of a device deployment issue (non- release of device) which led to device breakage and device misuse (coils cut) within the context of device difficult to use/complication of insertion.There were no reported medical events associated with the case.These technical events are not necessarily indicative of a quality defect.No complaint sample was provided for further technical investigation.No additional ae case reports have been received to date in relation to batch number b40025.No batch signal can be identified at this time.The review of the lot history records found that the product met product release specifications.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect".In summary, based on the available information there is no reason to suspect quality defect.Final assessment: lot history record (lhr) reviewed.Product met product release specifications.As of 04/09/2014, no device was returned; therefore, no device investigation could be completed.No conclusions can be drawn.Follow up information from 24-jun-2014: ptc result.Ptc global number: 2014-007571/1.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; and 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.Since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint.We were able to inspect the outer catheter, the inner catheter, and all parts within the handle assembly.No micro-insert was returned.Large tight pitch coil found to be stretched.All ifu steps were completed.No breakage was observed.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.We are unable to confirm any quality defect at this time.Medical assessment: this case refers to the technical event of a device deployment issue (non-release of device) which led to device breakage and device misuse (coils cut) within the context of device difficult to use/complication of insertion.There were no reported medical events associated with the case.The reported technical events are not necessarily indicative of a quality defect.The technical assessment concluded all ifu steps were completed, the complaint sample provided did not include the micro-insert (the implantable device) and with the provided complaint sample accounted for all pieces of the delivery system (of the device).Investigation showed that the tight pitch coils (portion of the delivery system) was actually stretched out but no breakage was observed.The technical investigation was unable to confirm any defect.No additional ae case reports have been received to date in relation to batch number b40025.No batch signal can be identified at this time.The review of the lot history records found that the product met product release specifications.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect" and observed no breakage with regard to the returned complaint sample.In summary, based on the available information there is no reason to suspect quality defect.Company causality comment: this medically confirmed case report refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted and experienced bad device release on the left, device remained attached to the introducer; the coil stretched until breakage; the coil was cut flush to the left ostium, and bilateral placement was not performed.Bad device release on the left, device remained attached to the introducer and the coil stretched until breakage are unlisted in the reference safety information for essure.The other events are listed.All events are considered non-serious.This case is regarded as near-incident due to device breakage.All events occurred during essure insertion procedure.As temporal relationship between bad device release on the left, device remained attached to the introducer and the coil stretched until breakage and essure insertion is positive, causality is assessed as related.Ptc investigation result: at the time of this medical assessment the technical investigation concluded "unconfirmed quality defect" and observed no breakage with regard to the returned complaint sample.In summary, based on the available information there is no reason to suspect quality defect.No further information is expected.Case closed.

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

• Brand Name: ESSURE
• Type of Device: KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 331 east evelyn avenue; mountain view CA 94041
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 3767745
• MDR Text Key: 4362653
• Report Number: 2951250-2014-00116
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: B40025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female