MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; OQY INTRAUTERINE BALLOON

Model Number G30673

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: 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 while treating a post partum hemorrhage, in which 800 ml of blood loss had already occurred, after a c-section a bakri tamponade balloon catheter was placed via the vagina with sponge forceps, but was found to leak after being inflated with 230 ml of saline.The operator implemented a "contraction treatment" along with the bakri.The operator then removed the device and found that the balloon had ruptured vertically, with the "split" measuring between 4 and 5 cm.Another bakri tamponade balloon catheter was placed to achieve hemostasis.80 ml of blood was lost after the second bakri balloon was placed.It was reported that no adverse effects to the patient occurred due to this malfunction.Additional details have been requested regarding the patient and event.At this time no additional information has been provided.A follow up report will be submitted when additional details are received.

Event Description

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

Manufacturer Narrative

Ec method code desc - 5: communication/interviews (4111).Investigation ¿ evaluation.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.One device was returned for investigation.Visual examination confirmed the catheter was returned in used condition.The balloon ruptured in a vertical direction.The line of rupture measured 6cm with a jagged area 2cm from the end of the balloon indicating a possible puncture.There were no scratches on the material.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.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.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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has determined that unintended user error contributed to 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.

Manufacturer Narrative

The investigation has been completed, and all known information and conclusions have been captured in previous reports.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 on 16feb2020: the blood loss volume between the 1st and 2nd bakri balloon placements was 200ml.The doctor was unable to provide further detail on what was meant by "contraction treatment.".

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9538687
• MDR Text Key: 178149638
• Report Number: 1820334-2020-00031
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)220115(10)9448806
• Combination Product (y/n): N
• 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
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2022
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9448806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 02/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 75