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

Model Number G30673

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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.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

It was reported, after a caesarean (c) section delivery, carbetocin, hemabate, and then uterine massage were used to treat postpartum hemorrhage (pph) due to uterine inertia.There was no improvement observed, and a bakri tamponade balloon catheter was placed transabdominally.The incision was sutured and the operator began to inflate the balloon.400ml of saline was injected into the balloon and leaking was observed.The device was immediately removed and it was discovered the balloon had ruptured.Hemostasis was finally achieved by gauze packing.There was approximately 400ml of blood loss after the bakri placement difficulties occurred and 800 ml of total blood loss.No adverse events have been reported as a result of the alleged malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.H6: method code: analysis of production records investigation ¿ evaluation: cook was informed on 28apr2020 of an incident involving a cook bakri postpartum balloon (j-sos-100500).As reported, the patient experienced postpartum hemorrhage due to uterine inertia, and blood loss was estimated to be 800ml.Medication treatment with carbetocin and hemabate was attempted, followed by uterine massage, but no improvement was observed.The bakri device was placed transabdominally.After the incision was sutured, the operator began to inflate the balloon.Leaking was noted when 400ml saline was injected.The operator removed the device immediately and found balloon ruptured seriously.Another bakri device was used to successfully complete achieve hemostasis.No related adverse events were reported.The complainant returned one bakri postpartum balloon catheter for investigation.J-sos-100500, reported lot confirmed.Visual examination confirmed the catheter was returned in used condition.The stopcock is attached to the inflation line and in the open position.Device was returned with a large amount of blood on the balloon and inside the catheter.The balloon is ruptured splitting the balloon vertically and horizontally around approximately ¾ the balloon circumference.In response to this incident, cook completed a review of the product dmr.It was concluded that adequate inspection activities have been established.A review of the device history record revealed no non-conformances related to the reported failure.A review of complaint records for the complaint lot revealed no other complaint received associated with this 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 lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Instructions for use supplied with this device 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.Conclusion: cook could not determine a definitive cause of this event.Per the quality engineering risk assessment, no additional risk mitigating activity is required.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.

Event Description

No new patient or even information since last report was submitted.

• 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: 10042469
• MDR Text Key: 193413210
• Report Number: 1820334-2020-00927
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)210215(10)8589590
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2021
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 8589590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR