MAUDE Adverse Event Report: WOMANCARE GLOBAL IPAS MANUAL VACUUM ASPIRATION (MVA); IPAS EASY GRIP CANNULAE; VACUUM ABORTION SYSTEM; CANNULA-SUCTION, UTERINE

Model Number MMKSU

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

Device was not made available.

Event Description

On 14 january 2016 - initial report received by wcg: womancare global was notified by (b)(4), of an adverse event that occurred on (b)(6) 2016 at (b)(6) hospital with use of the wcg mva (b)(4) kit, ln 140607 (ipas double-valve aspirator, 9mm easy grip cannula).The doctor reported that continuous bleeding from an exfoliated area (peeling site) of endometrium had occured from a missed abortion procedure; the bleeding was not due to a perforation.The doctor connected the aspirator and cannulae and unlocked the aspirator to perform the procedure but nothing happened.The doctor reported that the gestational sac (gs) was not collected during the initial uterine aspiration attempt.The doctor continued aspiration because the gs was not collected.However, uterus contraction deteriorated and much bleeding occurred.As the bleeding seemed to be more than normal, the doctor reported the event to (b)(4).The patient's condition was hospitalized overnight and was reported to be stable.It was not considered to be a life threatening condition.Note: distributor noted a possibility of incorrect use may have occurred and would provide report after obtaining additional information.On 3 february 2016 - follow-up - distributor sent email that the devices used for the procedure was disposed and not available for return.On 9 february 2016 - follow-up - the distributor provided a detailed report of procedure and investigation from interview with doctor (copied below): customer complaint report: detailed information was collected interviewed dr.(b)(6) on (b)(6) 2016.Background: (b)(6) 2016: dr.(b)(6) comments by phone: a patient underwent missed abortion surgery on (b)(6) 2016.Dr.Comments that nothing was aspirated even lock was released.He continued aspiration because gs was not collected.Meanwhile, the uterus contraction deteriorated and much bleeding occurred.It assumes that bleeding occurs from scar not perforation.Still bleeding continues at that time.(b)(6) 2016: dr.(b)(6) comments by email: after reexamining today's patient visit, condition improves, not completes yet.This case is diagnosed missed abortion with cesarean section history, and severe uterine retroversion.It is not serious condition, and reexamination will be one week later on friday.After that, report will be done.(b)(6) 2016: dr.(b)(6) comments by email: the cannula was connected to the aspirator and the valve buttons were released.Right after the suction was made, suction pressure was applied inside the uterus.Bloody contents were suctioned in the syringe, but the gestational sac (gs) was not noted.In my assumption, when the suction was made, the aperture of the cannula was facing the opposite direction from the gs.The suction pressure was not properly applied to the gs.Therefore, the gs was not removed completely, but it started to bleed from aspirated area.In this case, it assumes that aspiration is completed, however, tip of the cannula faces on the uterine wall.Only where attached area was aspirated, as a result, gs can not be collected.As a result, bleeding caused from the uterine wall more than expected.Anyhow, once this case outcome clears, dr.Will report.Patient information age: (b)(6), allergy: asthma, gravity: 1g parity: 1p, ga: (b)(6) weeks, diagnosis: missed abortion.Procedure: anesthesia drug: propofol; uterine contraction drug: methegine; size of cannula: 9mm; number of aspiration with mva: 1time; amount of contents collected: syringe was full(60ml); appearance if gs (gestational sac): none after aspirating by mva then d&c (curette and uterine tenaculum forceps) was done.Duration of mva procedure: 30sec (mva): changed to d&c right after the first aspiration, total procedure time: 10~15 (total).Any treatment needed (re-surgery, blood transfusion etc.): convectional d&c only gs size: 5cm; method used to check for completion of procedure: checked poc; complication(transfusion, re-surgery) : none; total amount of blood loss (during the procedure): 550ml; total amount of blood loss (post procedure) slight; hemoglobin count: before procedure: 11.5g/dl, after procedure: 10.9g/dl.Dr.(b)(6)'s comments by interview: (b)(6), 1g1p ga, (b)(6) weeks patient had severe uterus retroversion with cesarean section history.Procedure details: after cervical dilation, 9mm cannula was inserted.The cannula was connected to the aspirator and the valve buttons were released.Right after the suction was made, suction pressure was applied inside the uterus.Bloody contents were suctioned in the syringe, but the gestational sac (gs) was not noted.In my assumption, when the suction was made, the aperture of the cannula was facing the opposite direction from the gs.The suction pressure was not properly applied to the gs.Therefore, the gs was not removed completely, but it started to bleed from the area.Because the gs was not completely removed, contraction did not start.It caused to bleed more from the perforated area.Since it started to bleed more, i quickly stopped using mva and used forceps to remove the gs.Total blood loss was found 550ml and hematoma was noted in the uterus.To stop the bleeding, bimanual compression was done and methergine was given.No blood transfusion was needed.Normally, the amount of blood loss in this type of procedure is about 100ml.Bleeding was also noted around the scar from cesarean section.This laceration was probably made during cervical dilation.Patient was admitted to the hospital one night.It was within assumption that a patient had to hospitalize over night because dr.Gave informed consent to the patient before surgery.It is not assumed life threatening condition.Cesarean scar caused dilation was followed up on (b)(6) 2016.As for next visit, once next menstruation starts, the uterus contraction shall be examined.Future aspects: it assumes that if a hole of cannula (9mm) faces the different direction, gs could be collected into an aspirator.It suggests be instructed which direction the hole faces exanimated by ultrasound.It is not necessary to include a package insert.

• Brand Name: IPAS MANUAL VACUUM ASPIRATION (MVA); IPAS EASY GRIP CANNULAE
• Type of Device: VACUUM ABORTION SYSTEM; CANNULA-SUCTION, UTERINE
• Manufacturer (Section D): WOMANCARE GLOBAL; 12400 high bluff drive; suite 600; san diego CA 92130
• Manufacturer (Section G): PACIFIC HOSPITAL SUPPLY CO., LTD; no. 19, tzi-chiang road; tomg-lo industrial district; miaoli, miaoli 366 ; TW 366
• Manufacturer Contact: kelly culwell ; 12400 high bluff drive; san diego, CA 92130 ; 8583144025
• MDR Report Key: 6546386
• MDR Text Key: 74474108
• Report Number: 3008007615-2016-00002
• Device Sequence Number: 1
• Product Code: HHI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: MMKSU
• Device Catalogue Number: MMKSU
• Device Lot Number: 140607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR