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

Model Number G38432

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

It was reported that the needle was puncturing anterior to the biopsy line.The ultrasound manager was called in during the procedure and biopsy line was temporarily adjusted to represent where the needle was puncturing.During the following retrieval ultrasound was called in because the biopsy line had to be recalibrated back to its original position.The patient went to the emergency department several hours after the procedure to fix the internal bleeding.

Manufacturer Narrative

No device was returned for evaluation.No images were provided to assist with the investigation.Additional information was received from the district manager and it was advised that there were no visible damage to the needle or its tubing at opening and that the needle was pre-flushed as per the ifu.The complaint information was reviewed by the medical advisor in reproductive health who provided a clinical assessment.The medical advisor pointed out that the salient features are: 1.Routine egg retrieval procedure.After insertion of the needle, the operator could not see the needle tip on ultrasound, so the ultrasound manager was called, the guide line calibration altered, and the remaining follicles were drained.Needle was inspected post operatively, and no bend or kink was seen.2.In the next egg retrieval case, the ultrasound manager was again called, this time to recalibrate the machine back to the original settings.3.The skill/experience of the operator is not specified.4.The patient returned to the er department a few hours later, and ¿internal bleeding¿ was diagnosed and corrected.It is unclear whether the patient required hospital admission.The medical advisor assessed that: "this operator did not use correct procedures when unable to visualize the needle tip.The needle should never be advanced ¿blindly¿ without accurate visualization.If an experienced operator loses sight of the needle tip, the first thing to do is to leave the needle where it is, and to pull back the ultrasound probe slowly, allowing a wider view of the pelvic contents, and a view of the needle tip.Also, rotating the ultrasound probe often will bring into view a needle tip out of picture.Secondly, the patient required an emergency visit to the er department a few hours later, where she was diagnosed with ¿internal¿ bleeding.Unfortunately for us, there are two possible meanings to the use of the word ¿internal¿.Postoperative internal bleeding usually refers to intraperitoneal bleeding.This is a rare but documented side effect of any egg retrieval procedure.Diagnosis and treatment usually requires a laparoscopy and haemostasis achieved with either a cautery or sutures.However, patients can refer to internal bleeding as bleeding coming from their insides, revealed through the vaginal opening.This type of bleeding often settles with a simple suture applied to the patient¿s cervix or wherever the bleeding vessel is found, and this can be done with local anesthetic use.It is unclear whether this patient was admitted and had a general anesthetic.It sounds as if she may have been sent home from the er.This suggests to me that there was a problem with that first penetration of the needle.Some tough cervical tissue could have caused the needle to bend, but not permanently, the deviated tip then causing damage in its unseen trajectory through the patient¿s tissues.¿ the medical advisor emphasized that the event should not occur if standard operating procedures were followed.The medical advisor does not believe there was a fault in the needle based on the additional information received from the district manager that the needle was checked for damage.The medical advisor commented that: ¿the resistance to a temporary bending of the cook needle is considerable.I cannot imagine a needle being bent not being noted postoperatively; to move the needle tip outside the field of ultrasound view would necessitate enough of a bend to be easily seen.Finally, a miscalibration of the ultrasound equipment cannot be ruled out.However, note that the machine had to have the original settings restored for the next case does point to the needle use in the hands of the particular surgeon in this particular case¿ if the needle tip cannot be seen, the only course of action is to cancel the procedure, as blind needle insertion is dangerous".The device history record for a1086379 was reviewed and appears complete and correct.There were no temporary deviations effective, or non-conformances raised at the time of manufacture.The specifications were reviewed and there are a number of processes and checks in place which would identify a blunt or damaged needle prior to shipment.Based on the review of the event information the medical advisor does not believe there was a fault of the needle.The resistance to a temporary bending of the cook needle is considerable and the information provided indicates the use is dependent on the particular surgeon.The medical advisor pointed out that if the needle tip cannot be seen, the procedure must be cancelled.Based on the information, the most likely root cause(s) related to this complaint are: procedural complication.Insufficiently trained physician.

Event Description

It was reported that the needle was puncturing anterior to the biopsy line.The ultrasound manager was called in during the procedure and biopsy line was temporarily adjusted to represent where the needle was puncturing.During the following retrieval ultrasound was called in because the biopsy line had to be recalibrated back to its original position.The patient went to the emergency department several hours after the procedure to fix the internal bleeding.

• Brand Name: OVUM ASPIRATION NEEDLE SINGLE 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: majbrit frosig ; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 16739373
• MDR Text Key: 313304147
• Report Number: 9680654-2023-00024
• Device Sequence Number: 1
• Product Code: MQE
• UDI-Device Identifier: 00827002384323
• UDI-Public: (01)00827002384323(17)240826(10)A1086379
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G38432
• Device Catalogue Number: K-OSN-1725-B-60-US
• Device Lot Number: A1086379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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): Hospitalization