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

Catalog Number J-SOS-100500

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 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 initially reported on (b)(6) 2018, we received an order from yourselves, for bakri balloon j-sos-100500, the patient had these in place for less than 24 hours, on its removal the balloon was attempted to be deflated but no water was able to be drawn out.The balloon on removal had burst inside the uterus and appeared to look shredded.It was clearly documented at insertion in theatre that 500mls was inserted to inflate the balloon.The procedure is carried out and witnessed by a number of staff in this situation, therefore it is extremely unlikely that an error could have occurred in over inflation of the balloon.On (b)(6) 2018 , the following information was received in response to requests for additional information.Monday (b)(6) around lunchtime, it was inserted in a woman who had a sudden profuse post-partum hemorrhage (pph) a few hours following a trial of forceps in theatre.She was therefore taken to theatre for an evaluation under anesthesia (eua) under general anesthesia (ga) and the bakri was inserted at the end of the procedure.The device is not available for evaluation, it has been thrown away.The woman had a high bmi (around 40) but was otherwise generally fit and well.She was clearly haemodynamically compromised in a view of the pph, necessitating the use of a full major obstetric haemorrhage pack, to which she then developed an anaphylactic reaction requiring icu admission.She did not have any apparent uterine malformations.The balloon was inflated with 500ml of normal saline (as per usual).The physician stated, "i went to assess the patient 3-4 hours after the balloon insertion and noted a pool of light red fluid in her inco-pad (which happened just a few minutes before i arrived as the nurse had checked her inco-pad 20 minutes before my arrival and found it to be dry).At the time, i did not suspect that the balloon had burst so i removed the vaginal pack which she had and observed for bleeding.When i was reassured that this was minimal i left icu and reassessed her again the next day.I tried to deflate the balloon but there was no fluid to drain.It is then that i suspected that the balloon had torn (and realized that this must have occurred the previous afternoon).The tear (which was a full longitudinal one) was confirmed when i removed the balloon".The physician also reports there were no additional procedures required as the bleeding had settled and there were no adverse effects experienced by the patient due to the balloon tear.It has not been indicated that this adverse event was caused by the bakri balloon device; however, despite the attempt to obtain the cause of the anaphylactic reaction; this information has not yet been provided at the time of this report.

Manufacturer Narrative

Investigation ¿ evaluation: the complaint device was not returned for an evaluation and no photograph or imaging was provided.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, drawings, instructions for use, manufacturing instructions, quality control data, specifications, and trends.A review of the device history found no non-conformances.A review of complaint history records revealed no other complaints associated with the complaint device lot number 8938805.This device is shipped with the instructions for use (ifu) which states the proper warnings, precautions, and instructions for use.The ifu contains the following cautions related to this reported failure mode.To ensure that the balloon is filled to the desired volume, it is recommended that the predetermined volume of fluid be placed in a separate container, rather than relying on a syringe count to verify the amount of fluid that has been instilled into the balloon.Patient monitoring is an integral part of managing postpartum hemorrhage.Signs of deterioration or non-improving condition should lead to a more aggressive treatment and management of patient uterine bleeding.It is not known how frequently the patient was monitored.It is stated the patient was monitored and then monitored the next day.Per the ifu, patient monitoring is an integral part of managing postpartum hemorrhage.Signs of deterioration or non-improving condition should lead to a more aggressive treatment and management of patient uterine bleeding.Also, to adequately monitor hemostasis, the balloon drainage port and tubing may be flushed clear of clots with sterile isotonic saline.It is not known if force was used during placement.The ifu states to avoid excessive force when inserting the balloon into the uterus.The customer stated the balloon was inflated to 500cc but it is not known if this was the desired volume.Per the ifu, to ensure that the balloon is filled to the desired volume, it is recommended that the predetermined volume of fluid be placed in a separate container, rather than relying on a syringe count to verify the amount of fluid that has been instilled into the balloon.Based on the provided information an investigation conclusion could not be established.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

There has been no new information received since the 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: 7990304
• MDR Text Key: 126229696
• Report Number: 1820334-2018-03126
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)210608(10)8938805
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2021
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 8938805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other