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

Model Number G24237

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2020

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, following a c-section and during the treatment of post partum hemorrhage using a cook bakri postpartum balloon with rapid instillation components, the balloon was leaking.Contraction treatment was attempted, but the situation did not improve.The blood loss volume after the time was abut 1200ml.The operator then placed a bakri device transabdominally, sutured the incision, and began to inflate the balloon.When the inflation volume reached 300ml liquid began flowing from the patient's vagina.The bakri was immediately removed, and a pinhole was noted at the bottom of he balloon material.Hemostasis was achieved by using another device.The blood loss during this time was about 100ml.According to the initial reported, there were no adverse effects to the patient due to the alleged malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.H6: ec method code desc - 5: communication/interviews (4111).Investigation ¿ evaluation: it was reported on 27feb2020 of an incident involving a cook bakri postpartum balloon with rapid installation components.As reported, the complaint device was used to manage postpartum hemorrhage following a cesarean procedure.Blood loss was estimated to be 1200ml prior to use.The bakri was placed transabdominally, the incision was sutured, and balloon inflation was attempted.When the balloon volume reached about 300ml, liquid was found to be flowing out of the vagina.The device was immediately removed, and a pinhole leak was found in the bottom of the balloon material.Hemostasis was achieved by using another device.Blood loss was estimated to be 100ml.Further communication with the complainant clarified that the balloon was placed by hand, and no instruments or tools came into contact with the device.No related adverse events were reported.A visual inspection and functional testing of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, and quality control data.The complainant returned one bakri postpartum balloon catheter for investigation.Visual examination confirmed the catheter only was returned in used condition; instillation component was not returned.The stopcock is secured to the proximal end of the inflation line.A functional test was performed on the device by inflating the balloon with tap water.A leak was confirmed in the proximal end of the balloon material.Under magnification a hole was identified at the proximal end of balloon material causing it to leak.Balloon has been punctured by a sharp instrument.A review of the device history record (dhr) 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 related complaints from the lot 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: warns the maximum inflation is 500ml.Do not overinflate the balloon.Balloon should be inflated with sterile liquid.Balloon should never be inflated with air, carbon dioxide or any gas.The ifu also precautions to avoid excessive force when inserting the balloon into the uterus.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded unintended user error contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for 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

No new patient or event information to report since the last report was submitted.

• 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: 9764984
• MDR Text Key: 181960460
• Report Number: 1820334-2020-00486
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)210504(10)8862762
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2021
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 8862762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 55