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

Model Number G24237

Device Problem Material Rupture (1546)

Patient Problem Blood Loss (2597)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during the treatment of post-partum hemorrhage using a cook bakri postpartum balloon with rapid instillation components, the balloon ruptured.The device was placed 1 hour after delivery and inflated to 300ml with saline.The procedure was transvaginal, and the nature of the hemorrhage was atony.The patient was reported to have possibly had disseminated intravascular coagulation.There was 700ml of blood loss before placement of the device.The device was indwelling for 3 minutes.Following the device rupture, the patient received transfusion with one unit erythrocytes and fresh frozen plasma (hemoglobin 8.2g/dl).The patient also required curettage, b-lynch sutures, the use of an additional bakri postpartum balloon, tranexamic acid, and hysterectomy to achieve hemostasis.A section of the device did not remain inside the patient¿s body.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during the treatment of post-partum hemorrhage using a cook bakri postpartum balloon with rapid instillation components, the balloon ruptured.The device was placed 1 hour after delivery and inflated to 300ml with saline.The procedure was transvaginal, and the nature of the hemorrhage was atony.The patient was reported to have possibly had disseminated intravascular coagulation.There was 700ml of blood loss before placement of the device.The device was indwelling for 3 minutes.Following the device rupture, the patient received transfusion with one unit erythrocytes and fresh frozen plasma (hemoglobin 8.2g/dl).The patient also required curettage, b-lynch sutures, the use of an additional bakri postpartum balloon, tranexamic acid, and hysterectomy to achieve hemostasis.A section of the device did not remain inside the patient¿s body.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.Accordingly, no physical examination was performed.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.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 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 for use which state, ¿this device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.¿ contraindications of the device include, ¿[c]ases indicating hysterectomy¿ and ¿[a] surgical site that would prohibit the device from effectively controlling bleeding.¿ based on the information available, cook has concluded that no definitive cause for the event could be determined.Cook 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.

Event Description

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

• 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: 10573548
• MDR Text Key: 208145199
• Report Number: 1820334-2020-01734
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)230114(10)10263486
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2023
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 10263486
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention