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

Model Number G30673

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2022

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Device available for evaluation = unsure if device is available for return.Occupation = non-healthcare professional - unknown.Unsure if device will be returned.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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

It was reported that the balloon of a bakri tamponade balloon catheter ruptured.The postpartum patient was sent to the delivery room due to poor contraction of the lower uterine segment (uterine atony), and the [device] was used in the delivery room.Compression of the lower uterine segment [was used] to stop the bleeding (the capacity of the intrauterine balloon is 500ml) when 250ml of 0.9% sodium chloride injection is injected, the intrauterine balloon ruptures.The procedure was completed using a new device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.B5: additional information received 02jun2022.D9: device available for evaluation = yes.H3: device evaluated by manufacturer = device evaluation anticipated, but not yet begun.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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

Additional information received 02jun2022: there was 500ml blood loss prior to device deployment and 200ml blood loss after attempted deployment (total ebl 700ml).It was reported that the device was not handled by or in the proximity of any metal tools that may have damaged the balloon.The device is available for return and was sent on 14jun2022.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary it was reported that the balloon of a bakri tamponade balloon catheter ruptured.The postpartum patient was sent to the delivery room due to poor contraction of the lower uterine segment (uterine atony), and the [device] was used in the delivery room.Compression of the lower uterine segment [was used] to stop the bleeding (the capacity of the intrauterine balloon is 500ml) when 250ml of 0.9% sodium chloride injection is injected, the intrauterine balloon ruptures.There was 500ml blood loss prior to device deployment and 200ml blood loss after attempted deployment (total ebl 700ml).It was reported that the device was not handled by or in the proximity of any metal tools that may have damaged the balloon.The procedure was completed using a new device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use, and quality control data.The complaint device was returned for evaluation without packaging or labeling.Visual examination confirmed that the balloon material was torn in a "v" shape.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.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.A review of complaint history records shows no other complaints associated with the complaint device lot.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.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.

Event Description

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

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 14569482
• MDR Text Key: 300801676
• Report Number: 1820334-2022-00987
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)240110(10)13677329
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2024
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 13677329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 06/02/2022; 07/07/2022
• Supplement Dates FDA Received: 06/22/2022; 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female