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

Catalog Number J-SOSR-100500

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.Pma/510(k) #: 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 that during insertion of a cook bakri postpartum balloon with rapid instillation components to treat post-partum bleeding, they were unable to get the fluid out of the balloon.A second balloon from the same lot was used, and the end user was unable to get the fluid out of the second balloon as well.They were able to successfully completed the procedure using a third balloon.No adverse events have been reported as a result of the alleged malfunction.It is unclear whether they were testing the patency of the balloons prior to insertion or if this difficulty was discovered after the balloons had been inserted.Additional information was requested regarding the patient and the event.The complainant is unable to provide any additional information.

Event Description

Additional information provided on 03jan2019.To inflate the balloon, saline and the syringe and tubing included in the kit was used.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.The complaint device was not received for an evaluation.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, quality control data, and trends.A review of the device history record revealed no non-conformances.A review of the sub assembly device history records also revealed no non-conformances.A search of complaint records shows that this complaint is the only one associated with complaint lot number 8322251.The instructions for use (ifu) states the proper warnings, precautions, and instructions for use.1.Remove tension from balloon shaft.2.Remove any vaginal packing.3.Using an appropriate syringe, aspirate the contents of the balloon until fully deflated.The fluid may be removed incrementally to allow periodic observation of the patient.4.Gently retract the balloon from the uterus and vaginal canal and discard.No product has been returned for evaluation.The investigation found there were no other complaints related to this lot number.The cause of the reported issue could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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.

• 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: 8217286
• MDR Text Key: 132086783
• Report Number: 1820334-2019-00039
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)201025(10)8322251
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2020
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 8322251
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1