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

Lot Number B60760

Device Problems Sticking (1597); Difficult or Delayed Activation (2577); Activation, Positioning or Separation Problem (2906)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Type  No Answer Provided  

Event Description

Patient was having pain during procedure [procedural pain].Had to terminate the procedure [device insertion failed].Left the plastic in the uterus [complication of device insertion].When he rolled it back to release coil got stuck on the inserter catheter, inner catheter has uncoiled [device deployment issue].Left the plastic in the uterus [device breakage].Rolled the wheel back and it locked, had difficulty pressing the button.[device deployment issue].Case description: case summary: non-serious, related, unlisted, near-incident.This spontaneous case report was received from a health professional (hcp) in the united states on (b)(6) 2014.The report refers to a female patient of unspecified age who was to have essure (fallopian tube occlusion insert) inserted and when hcp rolled the wheel back and it locked, hcp had difficulty pressing the button, when he rolled it back to release coil got stuck on the inserter catheter and left the plastic in the uterus, hcp had to terminate the procedure.No information was given on patient's history, past drugs, concomitant medication and concurrent conditions.On (b)(6) 2014, the patient was to have essure (fallopian tube occlusion insert), lot number b60760 (expiration date august-2016) inserted.On (b)(6) 2014, hcp was in the or (operating room) and had to terminate the procedure.Hcp reported he passed the coil up to the black mark and then rolled the wheel back and it lock and had difficulty pressing the button.When he rolled it back to release the coil, it got stuck on the inserter catheter and left the plastic in the uterus.No further details were reported.Reporter did not assess device-event relationship.Follow-up information received on (b)(6) 2014: essure procedure went well.Button was hard to depress, finally depressed roll wheel, when went to withdraw tweezed it out.The inner catheter had uncoiled.But 2-3 cm of plastic sheath was left in place.Patient was having pain so the procedure was terminated.The physician believed the insert had deployed correctly.He planned to remove the green catheter sheath and would insert another coil in the other tube, as he did not do this on the first procedure.

Manufacturer Narrative

Ptc investigation result received on (b)(4) 2014: ptc global number: (b)(4).Evaluation summary - final assessment: lot history record (lhr) reviewed.Product met product release specifications.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: this case reported complication of device insertion due to breakage with catheter being caught in coil during rollback and caught piece remaining in uterus as well as a deployment issue due to button difficulty as well as the catheter being caught in coil.These events are not necessarily indicative of a quality defect.No complaint sample was provided for a technical investigation.No additional ae case reports have been received to date in relation to batch number b60760.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".Based on the information available, there is no reason to suspect a quality defect.Company causality comment: this medically confirmed, spontaneous case report, refers to a female patient who had an attempt to insert essure (fallopian tube occlusion insert) and during the procedure, the physician rolled the wheel back and it locked, had difficulty pressing the button; when he rolled it back to release coil got stuck on the inserter catheter; left the plastic in the uterus and had to terminate the procedure.Reporter causality assessment was not provided.All events were considered non-serious.Left the plastic in the uterus, interpreted as a device breakage, was regarded as a near-incident, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.This event is unlisted according to the reference safety information for essure, while the remaining events are listed.During difficult removals, single cases of essure breakage have been reported.In this particular case, it was reported that a device breakage occurred during a difficult insertion and the doctor had to terminate the procedure; considering that the reported events occurred during the placement procedure, they were considered as related to essure therapy.According to ptc final investigation, there is no reason to suspect a quality defect.

• Brand Name: ESSURE
• Type of Device: KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd; milpitas CA 95035
• Manufacturer Contact: k. lamberson, md ; 100 bayer blvd.; po box 915; whippany, NJ 07981-0915
• MDR Report Key: 3872087
• MDR Text Key: 20328179
• Report Number: 2951250-2014-00183
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Lot Number: B60760
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1