MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; OQY INTRAUTERINE BALLOON

Catalog Number J-SOSR-100500

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: k170622.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during the treatment of pph (post partum hemorrhage) following a cesarean section, the blue inflation valve from a cook bakri postpartum balloon with rapid instillation components was left in a patient's uterus.In the process of placing the device, the inflation valve fell off into the patient's uterus.Another inflation valve was used, and the pph was controlled.The missing inflation valve came out of the patient a few days later.No additional consequences to the patient have been reported.The event occurred in 2016, but it was not reported to the manufacturer until 08jan2020.Additional information has been requested.No additional details are known at this time.A follow up report will be submitted if additional information is received.

Manufacturer Narrative

H6: ec method code: communication/interviews (4111).Investigation ¿ evaluation.As reported, the bakri device was used to manage severe postpartum hemorrhage following a cesarean section.The physician left the blue inflation valve on the proximal end of the catheter as it came out of the package, and then lost it in the uterus of the patient during the process of putting the catheter device in situ.Another inflation valve from a different bakri device was used to inflate the balloon and achieve homeostasis.The patient spontaneously passed the missing inflation valve a few days later.No adverse effects were reported as a result of this incident.Reviews of complaint history, device history record, trends, quality control data and the instructions for use(ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: instructions for use: "transabdominal placement, post-cesarean section" "1.Determine uterine volume by direct examination." "2.From above, via access of the cesarean incision, pass the tamponade balloon, inflation port first, through the uterus and cervix." "note: remove and stopcock to aid in placement and reattach prior to filling balloon." "3.Have an assistant pull the shaft of the balloon through the vaginal canal until the deflated balloon base comes into contact with the internal cervical ostium." "4.Close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing." how supplied: "upon removal from the package, inspect the product to ensure no damage has occurred." the instructions for use for this product, state for transabdominal placement, post-cesarean section: "remove and stopcock to aid in placement and reattach prior to filling balloon." as reported, the user did not follow this instruction.Cook has concluded that a failure by the user to follow instructions contributed to this event.The risk analysis for this failure mode was reviewed and additional escalation is not recommended.We will continue our monitoring of similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

There is no new patient or event information to report.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9590664
• MDR Text Key: 177839354
• Report Number: 1820334-2020-00111
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2018
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 6387496
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1