MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD OVUM ASPIRATION NEEDLE DOUBLE LUMEN; MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES

Catalog Number K-OPSD-1635-A-L

Device Problems Dull, Blunt (2407); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

This report covers 3 events where no patient harm was experienced, but there was a potential for harm.2 of the 3 used devices along with 31 unused devices are expected to be returned for evaluation.

Event Description

From original (b)(4): the needles with lot no a1122951 were not able to perforate the follicles, aspirate the follicular fluid and some of patient's oocytes lost.Subsequently the patients took more sedation than usual.Additional information received: how many cases were involved? how many surgeons? 6 cases and 2 different surgeons.The one doctor, has more than 30 years of experience.Was the echo-tipping visible under ultrasound? yes, it was visible.Did the operator also have difficulties while perforating the vaginal vault and/or the ovarian capsule? yes, there were difficulties while perforating both the vaginal vault and the ovarian capsule.Were the needles pre flushed? yes.Was there any surface damage or bluntness or any visual abnormality observed on the needles? no.What was the patient's outcome in each case.Any reported harm to a patient or need for additional procedure? in each case fewer eggs than expected were retrieved.All of the patients got larger amount of sedation, and in 3 of the 6 cases bleeding occurred.The customer has now mentioned 6 cases (we have sent 2 of the 6 because the rest of them were full of blood clots and it was impossible to be washed and cleaned).Could it be confirmed that the reported 6 cases were related to the same lot # a1122951? if not, what other lot # were involved? the lot # was the same.For the 3 cases that presented bleeding, what was the patient's outcome in each case.Was any additional procedure needed to stop the bleeding? in all cases the doctors were dabbing with increased pressure using 2 hands and used big tampons.After a while the bleeding stopped.This (b)(4): the needles were not able to perforate the follicles to aspirate the follicular fluid, some patients oocytes lost.The patients required more sedation than usual.All related prs: (b)(4): 3 patients.The needles were not able to perforate the follicles to aspirate the follicular fluid, some patients oocytes lost.The patients required more sedation than usual.(b)(4): 1 patient.The needle was not able to perforate the follicles to aspirate the follicular fluid, some of the patients oocytes lost.The patient required more sedation than usual.Excess bleeding.(b)(4): 1 patient.The needle was not able to perforate the follicles to aspirate the follicular fluid, some of the patients oocytes lost.The patient required more sedation than usual.Excess bleeding.(b)(4): 1 patient.The needle was not able to perforate the follicles to aspirate the follicular fluid, some of the patients oocytes lost.The patient required more sedation than usual.Excess bleeding.

Event Description

From original (b)(4): the needles with lot no a1122951 were not able to perforate the follicles, aspirate the follicular fluid and some of patient's oocytes lost.Subsequently the patients took more sedation than usual.Additional information received: - how many cases were involved? how many surgeons? 6 cases and 2 different surgeons.The one doctor, has more than 30 years of experience.- was the echo-tipping visible under ultrasound? yes, it was visible - did the operator also have difficulties while perforating the vaginal vault and/or the ovarian capsule? yes, there were difficulties while perforating both the vaginal vault and the ovarian capsule - were the needles pre flushed? yes - was there any surface damage or bluntness or any visual abnormality observed on the needles? no - what was the patient's outcome in each case.Any reported harm to a patient or need for additional procedure? in each case fewer eggs than expected were retrieved.All of the patients got larger amount of sedation, and in 3 of the 6 cases bleeding occurred.-the customer has now mentioned 6 cases (we have sent 2 of the 6 because the rest of them were full of blood clots and it was impossible to be washed and cleaned) - could it be confirmed that the reported 6 cases were related to the same lot # a1122951? if not, what other lot # were involved? the lot # was the same - for the 3 cases that presented bleeding, what was the patient's outcome in each case.Was any additional procedure needed to stop the bleeding? in all cases the doctors were dabbing with increased pressure using 2 hands and used big tampons.After a while the bleeding stopped.This (b)(4): the needles were not able to perforate the follicles to aspirate the follicular fluid, some patients oocytes lost.The patients required more sedation than usual.All related prs: (b)(4): 3 patients.The needles were not able to perforate the follicles to aspirate the follicular fluid, some patients oocytes lost.The patients required more sedation than usual.(b)(4) 1 patient.The needle was not able to perforate the follicles to aspirate the follicular fluid, some of the patients oocytes lost.The patient required more sedation than usual.Excess bleeding.Pr404856 1 patient.The needle was not able to perforate the follicles to aspirate the follicular fluid, some of the patients oocytes lost.The patient required more sedation than usual.Excess bleeding.(b)(4) 1 patient.The needle was not able to perforate the follicles to aspirate the follicular fluid, some of the patients oocytes lost.The patient required more sedation than usual.Excess bleeding.

Manufacturer Narrative

Two of the three reported used needles involved in the procedures resulting in the reported issues were not returned for evaluation.31 unused, unopened needles were also returned.The returned devices were sent for further evaluation by the subject matter expert.The tips were checked for sharpness and echo tipping was inspected.All of the 31 unused, unopened needles passed inspection with no issues detected.Visual inspection of the 2 used needles confirmed that the devices were returned in used condition, with clear liquid in the tubing lines and traces of biological matter and contamination in the tips.Both needle tips were visually inspected for any surface damage or bluntness.The tip of needle # 1 appeared sharp and straight.The tip of the needle # 2 was not straight and was noted to be slightly bent.No imaging was received to assist the investigation.The event information was was provided to the medical advisor in order to provide a clinical assessment, which stated the following: 'passage of the needle through the vaginal vault can ¿core¿ off a piece of that tissue which can block the needle and make the suction weak or zero.This is the most likely cause of this complaint.The operator has to pierce three structures to reach the follicular fluid.The follicle capsule ¿ the thinnest of the three.If the ovary is normally placed and well visualised, this is the easiest of the penetration moves.Suction is kept on until the follicle is empty, when the needle is moved into the adjacent follicle, still with suction maintained.The operator/s when faced with a situation of controlling the needle within the ovarian substance which will not suck follicular fluid, often may choose to push harder, with increased risk of tearing of the follicle wall or ovarian substance, with consequent follicular fluid and oocyte losses ¿ and increased ovarian pain".Review of device history record (dhr) found the work order for lot a1122951 appeared complete, and the quality control inspection was verified to ensure that the devices passed inspection.5 non-conforming devices were rejected.There is no evidence that a device non-conformance or deficiency contributed to the reported event.The associated inspection record confirms that the devices were manufactured to specification.There were no temporary deviations in place at the time of manufacture.Review of specifications found that there are a number of processes and checks in place which would identify a blunt or damaged needle prior to shipment.Based on the available information, and inspection of the returned product, a definitive root cause could not be determined.The potential root causes are: - blockage from patient¿s tissues - needle problems ¿ not sharp enough, needle blunted by patient tissue - procedural complications.

• Brand Name: OVUM ASPIRATION NEEDLE DOUBLE LUMEN
• Type of Device: MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 17467378
• MDR Text Key: 320485844
• Report Number: 9680654-2023-00098
• Device Sequence Number: 1
• Product Code: MQE
• UDI-Device Identifier: 00827002304154
• UDI-Public: (01)00827002304154(17)251201(10)A1122951
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K983593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: K-OPSD-1635-A-L
• Device Lot Number: A1122951
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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