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-1730-A-L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intra-Abdominal Hemorrhage (4479)

Event Date 07/17/2023

Event Type  Injury  

Manufacturer Narrative

Although the complaint device is not available for evaluation, unused devices of the same lot number are expected to be returned for evaluation.

Event Description

Hemoperitoneum after ovum pick up (opu) procedure.Puncture started at 9.15 am, time of the procedure 15 mn, on local anesthesia.The hemoperitoneum appeared in the afternoon.The retrieval opu was performed by a highly experienced doctor.The patient was taken to the operating theatre for laparoscopy 1200ml of blood was recovered.(b)(6) are for the same event for the same patient.All related pr's: (b)(6) are for the same event for the same patient.(pt 1); (b)(6) are for the same event for the same patient.(pt 2); (b)(6) are for the same event for the same patient.(pt 3).

Manufacturer Narrative

Although the used complaint device relating to this event was not returned for evaluation, 4 unused needles from the same lot number were returned for evaluation.The investigator found ¿the returned devices were sent for further evaluation by the subject matter expert.The tips were checked for sharpness and echo tipping was inspected.1 needle failed the inspection and the 3 remaining needles passed inspection with no issues detected.No imaging was received to assist the investigation.Review of device history record (dhr) found the work order for lot a1091044 and the related room stock work orders appeared complete, and the quality control inspection was verified to ensure that the devices passed inspection.14 non-conforming devices were rejected (11 for packaging issues, 2 due to component out of specification and 1 device was rejected due to missing component.) 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.The medical advisor reviewed the reported event and stated: "haemoperitoneum¿ by definition, this is the presence of blood lying freely within the peritoneal cavity.In most cases it implies here a hole in a blood vessel that cannot seal itself over by the usual clotting, spasm and wound healing.This is a dangerous, rare, well recognized complication of oocyte retrieval, in which sharp needles puncture ovarian capsules, then follicles which are highly metabolically active, with lots of blood flow through the walls.It is generally taught that the incidence of this complication is 1/1,000 egg retrievals (or slightly less).It is possible we are just seeing a statistical ¿clump¿ of cases.Haemoperitoneum was the case in all the laparoscopies and coelioscopy ¿ with blood losses around 1-2 liters.Once again, all these cases seemed to happen in french ivf units.I have no idea why that should be so, though it does suggest a systemic cause may have an influence".Clinical evaluation report for ovum pick-up needles and sets addresses the following: - hemorrhage/bleeding is well-known and described in the literature as a possible adverse event occurring from the use of any ovum pick-up needle during the oocyte collection procedure.- in conclusion, the cook ovum pick-up needles and sets are considered to be safe and effective and to be in accordance with the state-of-the-art for their intended use.An earlier corrective and preventative action (capa) was initiated to address an increase of bleeding after using cook ovum pick-up needles.After an extensive investigation into manufacturing processes, temporary deviations during manufacture from jan-2019 to jun-2022, needle design, design changes on single and double lumen devices over the last 3 years, assessment of clinical factors, and evaluation of returned complaint products both in-house and by puncture strength, puncture durability and drag force test, a single root cause could not be identified.The manufacturer has a quality management system (qms) requirement to always review the complaint history during a complaint investigation to ensure that trends are constantly monitored.Based on the available information, and inspection of the returned product, a definitive root cause could not be determined.The potential root causes are: - patient related factors - procedural complications.

Event Description

Hemoperitoneum after ovum pick up (opu) procedure.Puncture started at 9.15 am, time of the procedure 15 mn, on local anesthesia.The hemoperitoneum appeared in the afternoon.The retrieval opu was performed by a highly experienced doctor.The patient was taken to the operating theatre for laparoscopy 1200ml of blood was recovered.(b)(4) and (b)(4) are for the same event for the same patient.All related pr's: (b)(4) and (b)(4)are for the same event for the same patient.(pt 1) (b)(4) and (b)(4) are for the same event for the same patient.(pt 2) (b)(4) and (b)(4) are for the same event for the same patient.(pt 3).

• 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: 17561822
• MDR Text Key: 321313475
• Report Number: 9680654-2023-00104
• Device Sequence Number: 1
• Product Code: MQE
• UDI-Device Identifier: 00827002304635
• UDI-Public: (01)00827002304635(17)241116(10)A1091044
• Combination Product (y/n): N
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: K-OPSD-1730-A-L
• Device Lot Number: A1091044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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 Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 54 KG