MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; OQY INTRAUTERINE BALLOON

Catalog Number UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: between (b)(6) 2010-(b)(6) 2011.Rpn: either j-sos-100500 or j-sosr-100500.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported in ¿success factors for bakri® balloon usage secondary to uterine atony: a retrospective, multicenter study¿ appearing in a 2015 edition of australian and new zealand journal of obstetrics and gynaecology, in 2 patient cases, the bakri balloon was expelled from the uterus immediately after insertion and filling.(the second patient is reported in patient identifier (b)(6)).Available details and sequence of events are as follows: following a vaginal delivery, the third stage of labor (defined as the period of time between when the infant is born and the placenta separates from the uterine wall and passes through the vagina) was actively managed with administration of prophylactic uterotonic medication (oxytocin) at a rate between 5-10 iu initiated after the delivery of infant shoulders.Additional care measures performed during the third stage of labor consisted of lower genital tract examination to diagnose and repair any lacerations, uterine exploration to ensure uterine cavity is empty, and in case of placental retention-manual removal of the placenta and continuous infusion of oxytocin at 10 iu/hour.After these measures, bleeding due to uterine atony continued 30 minutes or exceeded 500ml.At this time, oxytocin was ceased and a second-line uterotonic agent (typically sulprostone: 500mcg over 1 hour, then 500mcg over 4-6 hours together with anesthetic management) was initiated simultaneously with uterine massage and bimanual compression.These measures failed to stop the bleeding and a cook bakri tamponade balloon catheter was placed transvaginally and was filled with sterile saline per the manufacturers instructions (initially with 300ml and up to 500ml dependent on the resistance of the uterus).The bakri balloon was expelled from the uterus immediately after insertion and filling.Hemostasis was achieved (it is unstated how), and no further procedures were needed.No additional consequences to the patient have been reported as a result of this occurrence.Additional details regarding the patient and event have been requested from the contact author.At this time, no additional information has been provided.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Event summary: it is reported in ¿success factors for bakri® balloon usage secondary to uterine atony: a retrospective, multicenter study¿ appearing in a 2015 edition of australian and new zealand journal of obstetrics and gynaecology, in 2 patient cases, the bakri balloon was expelled from the uterus immediately after insertion and filling.After multiple measures failed to stop post-partum bleeding following a vaginal delivery, a cook bakri tamponade balloon catheter was placed transvaginally and was filled with sterile saline per the manufacturer¿s instructions (initially with 300ml and up to 500ml dependent on the resistance of the uterus).The bakri balloon was expelled from the uterus immediately after insertion and filling.Hemostasis was achieved (it is unstated how), and no further procedures were needed.Investigation - evaluation: reviews of the instructions for use and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.No product lot was provided.Accordingly, no physical examinations, complaint history review, or device history record review could be conducted.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use, which state, ¿to prevent displacement of the balloon of the balloon into the vagina, counterpressure can be applied by packing the vaginal canal with iodine- or antibiotic-soaked gauze." based on the available information, cook has concluded that a cause could not be determined.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10412867
• MDR Text Key: 203156990
• Report Number: 1820334-2020-01500
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1