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

Catalog Number UNKNOWN

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

Patient Problems Urinary Retention (2119); Hematuria (2558)

Event Date 12/02/2019

Event Type  Injury  

Event Description

A (b)(6) woman presented to the emergency room (er) reporting voiding difficulty and hematuria 3 days after transvaginal oocyte retrieval (tvor).Three days after tvor, the patient complained of urinary retention and gross hematuria.She also reported dysuria, with increased frequency and urgency.Her vital signs were all within the normal range.An abdominal examination revealed suprapubic tenderness.There was no flank knocking pain or costovertebral tenderness.Urinalysis confirmed a large amount of blood.Laboratory tests indicated a normal hematocrit, and normal leukocyte, platelet, and electrolyte counts.A transabdominal ultrasound showed a complex mass (4.3 _ 3.1 cm) interposed between the anterior bladder wall and posterior bladder wall, and bilateral enlarged cystic ovaries (right: 56 _ 37 mm, left: 74 _ 55 mm).A bladder hematoma resulted for oocytes puncture was suspected.The patient was then admitted, and catheterized using a threeway foley catheter for bladder irrigation.On the 4th day of hospitalization, we performed a follow-up ultrasound, and it showed a persisted hematoma in the bladder, as similar as previous imaging.To check the possibility of active bleeding site and to remove the dense bladder clots, the urogynecologist applied diagnostic cystoscopy under general anesthesia.The cystoscopy demonstrated a blood clot near the trigon and a hyperemic patch in the right lateral wall of bladder.Based on the site and the mode of injury, the area might be the site of needle puncture or contusion from vaginal probe.Since active bleeding was not seen, the experienced urogynecologist performed bladder irrigation with an ellik evacuator.The foley catheter was removed without complications on the following day, and she was discharged 2 days afterwards.

Manufacturer Narrative

The device was not returned for evaluation.A review of the device history record could not be conducted because the lot number was not provided.Hematuria may occur due to the aspiration needle penetrating a filled bladder during transvaginal ultrasound aspiration.This complication typically resolves spontaneously within a day.Extravasation of urine may occur within the abdominal cavity when the needle puncture traverses the bladder.Patients should be monitored for evidence of this known complication, however, there is typically no associated discomfort or adverse sequelae.A definitive root cause could not be determined from the available information.The information in the complaint does not indicate a clear device failure.

Event Description

A 35-year-old woman presented to the emergency room (er) reporting voiding difficulty and hematuria 3 days after transvaginal oocyte retrieval (tvor).Three days after tvor, the patient complained of urinary retention and gross hematuria.She also reported dysuria, with increased frequency and urgency.Her vital signs were all within the normal range.An abdominal examination revealed suprapubic tenderness.There was no flank knocking pain or costovertebral tenderness.Urinalysis confirmed a large amount of blood.Laboratory tests indicated a normal hematocrit, and normal leukocyte, platelet, and electrolyte counts.A transabdominal ultrasound showed a complex mass (4.3 _ 3.1 cm) interposed between the anterior bladder wall and posterior blassder wall, and bilateral enlarged cystic ovaries (right: 56 _ 37 mm, left: 74 _ 55 mm).A bladder hematoma resulted for oocytes puncture was suspected.The patient was then admitted, and catheterized using a threeway foley catheter for bladder irrigation.On the 4th day of hospitalization, we performed a follow-up ultrasound, and it showed a persisted hematoma in the bladder, as similar as previous imaging.To check the possibility of active bleeding site and to remove the dense bladder clots, the urogynecologist applied diagnostic cystoscopy under general anesthesia.The cystoscopy demonstrated a blood clot near the trigon and a hyperemic patch in the right lateral wall of bladder.Based on the site and the mode of injury, the area might be the site of needle puncture or contusion from vaginal probe.Since active bleeding was not seen, the experienced urogynecologist performed bladder irrigation with an ellik evacuator.The foley catheter was removed without complications on the following day, and she was discharged 2 days afterwards.

• Brand Name: UNKNOWN
• 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 QLD 4 113; AS QLD 4113
• MDR Report Key: 9500037
• MDR Text Key: 186601909
• Report Number: 9680654-2019-00051
• Device Sequence Number: 1
• Product Code: MQE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR