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

Model Number G24237

Device Problem Fluid/Blood Leak (1250)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

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 during treatment of post-partum hemorrhage (pph) after delivery (mode of delivery unspecified), the patient received (unspecified) medication treatment which didn't improve the situation much.Next, a cook bakri postpartum balloon with rapid instillation components was inserted.After 300ml of saline was injected, the balloon didn't inflate to expected estimated size under ultrasound.The operator removed the device and found the balloon was leaking.Hemostasis was achieved with another new device.There were no adverse effects to the patient reported as a result of this occurrence.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Corrected information: h1.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.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: section c investigation ¿ evaluation event description: cook was informed of an incident involving a cook bakri postpartum balloon with rapid installation components.As reported, the complaint device was used to treat postpartum hemorrhage.The device was not handled with any instruments prior to or during placement.After placement, 300ml of saline was injected, and the balloon did not inflate as expected.The operator removed the device and found the balloon to be leaking.Hemostasis was achieved using another new device.Blood loss prior to the bakri placement was estimated to be 1500ml and then 800ml after the difficulty.No additional patient consequences 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, specifications, and quality control data.The complainant returned one open bakri postpartum balloon catheter for investigation.Visual examination confirmed the catheter was returned in used condition.Catheter was returned without the instillation components or stopcock.The device was returned with liquid inside the balloon.A leak test was performed by flushing tap water through the catheter to fill the balloon; a leak was confirmed in the balloon.Under magnification, indentations from an instrument were identified, one of the indentations punctured through the balloon material causing it to leak.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.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.A review of complaint history records shows no other complaints associated with the complaint device lot.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.How supplied: "upon removal from the package, inspect the product to ensure no damage has occurred." a clinical assessment was completed.Based on the available information, the most likely factors contributing to this event include patient condition (placenta previa-high risk of post-partum hemorrhage/placenta trauma), user technique/procedure related.Most probable cause of balloon damage is use related.Evaluation of the device determined that the complaint device was likely damaged by an instrument of undetermined origin, however the customer confirmed that the device was not handled by any metal tools.Cook could not determine a definitive cause of this event.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

Additional information was received 29jun2020: it was reported, the leak was coming from a hole in the balloon material.Blood loss prior to device placement was approximately 1500 ml.Blood loss after placement was approximately 800 ml.The nature of the post-partum hemorrhage (pph) was placenta previa.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

• 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: 10180876
• MDR Text Key: 196426533
• Report Number: 1820334-2020-01166
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)210608(10)8938759
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2021
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 8938759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 28 YR
• Patient Weight: 60