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

Catalog Number J-SOSR-100500

Device Problem Inflation Problem (1310)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Product lot #: exact lot has not been identified, but was reported as either (13142605 or 13307718).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 treatment of a post-partum hemorrhage secondary to uterine atony, two cook bakri postpartum balloons with rapid instillation components leaked.Both devices were placed transvaginally using the rapid instillation components two hours following a caesarean delivery.While injecting the first device (patient identifier (b)(6)) with 100ml saline, a lengthwise crack was observed at the connection between the instillation line and the one-way valve.The device was thus replaced with a second balloon (patient identifier (b)(6)), which also failed.A third balloon was used to successfully complete the procedure.An unspecified amount of bleeding was reported, but the patient did not require a transfusion.A section of the device did not remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.According to the initial reporter, the patient did experience adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: as reported, during treatment of a post-partum hemorrhage secondary to uterine atony, two cook bakri postpartum balloons with rapid instillation components leaked.Both devices were placed transvaginally using the rapid instillation components two hours following a caesarean delivery.While injecting the first device (this report) with 100ml saline, a lengthwise crack was observed at the connection between the instillation line and the one-way valve.The device was thus replaced with a second balloon (reference mdr # 1820334-2021-00318), which also failed.A third balloon was used to successfully complete the procedure.An unspecified amount of bleeding was reported, but the patient did not require a transfusion.A section of the device did not remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.According to the initial reporter, the patient did experience adverse effects due to this occurrence.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, device history record (dhr), the instructions for use (ifu), and quality control data.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 this device was manufactured out of specification.A review of the device history record for both potential production lots found no non-conformances related to the reported failure mode.Aside from the related complaint (reference mdr # 1820334-2021-00318), a review of complaint history records shows no other complaints associated with the complaint device lots.Due to the individual nature of the manufacturing and inspection process for the devices in the lots, it is unlikely that these events are an indication of device issue within either entire production lot.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." the most probable cause of the reported event could not be determined from the available information.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue to monitor 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

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: 11318015
• MDR Text Key: 247746614
• Report Number: 1820334-2021-00317
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1