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 Problem Blood Loss (2597)

Event Date 10/10/2020

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 was reported, during treatment of post partum hemorrhage (pph) following a cesarean section using a cook bakri postpartum balloon with rapid instillation components, there was leakage through a pinhole.500 ml of blood was lost before any device placement, so the operator placed the balloon abdominally by hand and injected it with 400 ml of saline.At a later time, liquid had flowed out of the vagina.The operator removed the balloon and discovered the pinhole in the balloon material that caused the leakage.Hemostasis was achieved by using another new balloon.Total blood loss was about 3000 ml.The initial reporter noted there were no other adverse effects on the patient due to the occurrence.

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 was reported, during treatment of post-partum hemorrhage (pph) following a cesarean section using a cook bakri postpartum balloon with rapid instillation components, there was leakage through a pinhole.500ml of blood was lost before any device placement, so the operator placed the balloon abdominally by hand and injected it with 400ml of saline.At a later time, liquid had flowed out of the vagina.The operator removed the balloon and discovered the pinhole in the balloon material that caused the leakage.Hemostasis was achieved by using another new balloon.Total blood loss was about 3000ml.The initial reporter noted there were no other adverse effects on the patient due to the occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, specifications, and quality control procedures and a visual inspection of the device were conducted during the investigation.One bakri postpartum balloon catheter was returned for investigation in a used condition.The stopcock was attached to the inflation line.A function test was performed by inflating the balloon with tap water during which water leaked from the balloon.Under magnification, track marks were visible on the balloon material; one of the marks punctured through the material, causing the balloon to leak.A document-based investigation evaluation was also performed.No related non-conformances were recorded, and no other lot-related complaints have been received.The device history record review provides objective evidence that the device was manufactured to specification.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 manufacturing instructions, specifications, or quality control 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 which state after device placement to, ¿close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing.¿ based on the available information, cook has concluded that the most probable cause of the puncture could not be determined.Cook will continue 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: 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: 10826178
• MDR Text Key: 217956066
• Report Number: 1820334-2020-02076
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)210608(10)8938765
• 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
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• 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: 8938765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 34 YR
• Patient Weight: 55