MAUDE Adverse Event Report: CONVATEC, INC. ABVISER - INTRA ABDOMINAL PRESSURE MONITOR; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number ABV321

Device Problem No Flow (2991)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No lot number is available, a detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Event Description

A nurse reported that the auto valve of the abviser did not automatically reopen after taking a measurement resulting in urinary retention for the patient.The abviser was used on a patient in an intensive care unit setting beginning (b)(6) 2016 at approximately 7:30pm to monitor the patient's intra-abdominal pressures due to severe abdominal distention and firmness.The patient had biliary leakage into the peritoneal cavity for which a couple of drains had been inserted to relieve the pressure.The patient's urine was reported to be very viscous and thick throughout the use of the abviser and foley catheter.It was reported that the device was properly primed and prepped according to the information for use and working fine throughout the evening; pressure readings were between 10 and 11.At some point during the night, the catheter stopped draining and on the morning of (b)(6) 2016, after compressing the plunger and waiting, the auto valve did not automatically open or drain; the abviser was discontinued but the foley catheter was left in place.The patient began complaining of pain and an ultrasound of the bladder showed 180cc's of retained urine, due to this retention the patient had developed elevated blood pressure and required additional pain medication.The patient continued to experience discomfort and it was noted that the foley catheter was not properly draining.When a new catheter was inserted, the patient began to leak urine and a large blood clot was expelled giving the patient some immediate relief.The nurse reported that he inspected the abviser and found that the auto-valve was deflated.Additionally, he felt that the issue was not related to the abviser, but most likely was a result of the blood clot (it is unknown how long after discontinuation of the device the inspection took place).The patient has since been discharged from the hospital.

Manufacturer Narrative

Received a used section of an adviser for evaluation.The product sample was disposed of as per procedure.Therefore, this complaint will be closed with no further actions required.No additional patient/ event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: ABVISER - INTRA ABDOMINAL PRESSURE MONITOR
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue, suite 400; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5721053
• MDR Text Key: 47269230
• Report Number: 1049092-2016-00278
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: ABV321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention